FDA-cleared K161201
ClearRead CT
RIVERAIN TECHNOLOGIES, LLC
ClearRead CT provides adjunctive information and is not intended to be used without the o.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2016-09-09
Modality
CT/CTA radiology AI tools
360 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
FDA-cleared K161322
CT CoPilot
ZEPMED, LLC.
CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2016-12-07
FDA-cleared K163622
Lung Vision
BODY VISION MEDICAL LTD.
cations for Use LungVision System Indications for Use: The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2017-05-11
FDA-cleared K170250
SmartTarget
SmartTarget, Ltd.
SmartTarget ,QGLFDWLRQVIRU8VH(Describe) The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland,...
- Modality
- CT/CTA
- Anatomy
- Prostate
- Decision
- 2017-06-07
FDA-cleared K173542
Arterys Oncology DL
Arterys Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2018-01-25
FDA-cleared K180161
Viz CTP
Viz.ai, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-04-20
FDA-cleared K173821
LungQ Software
Thirona Corporation
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2018-06-05
FDA-cleared K172983
HealthCCS
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-06-13
FDA-cleared K173444
Quantitative Total Extensible Imaging (QTxI)
AIQ Solutions, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-07-23
FDA-cleared K180647
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-08-01
FDA-cleared K182177
Accipiolx
MaxQ-Al Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-10-26
FDA-cleared K182616
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-11-02
FDA-cleared K181939
icobrain
icometrix NV
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-11-06
FDA-cleared K181247
Vitrea CT Brain Perfusion
Vital Images, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2018-11-20
FDA-cleared K183012
vascuCAP
Elucid Bioimaging Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-12-21
FDA-cleared K182130
iSchemaView RAPID
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2018-12-27
FDA-cleared K183133
MRCP+ v1.0
Perspectum Diagnostics Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-01-09
FDA-cleared K183272
AI Rad Companion (Engine)
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-02-01
FDA-cleared K183019
SIS Software version 3.3.0
Surgical Information Sciences, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-03-19
FDA-cleared K183204
Bone VCAR (BVCAR)
GE Medical Systems SCS
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2019-04-08
FDA-cleared K183202
Deep Learning Image Reconstruction
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-04-12
FDA-cleared K190072
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-04-15
FDA-cleared K190896
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-05-31
FDA-cleared K183046
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-06-12
FDA-cleared K190424
HealthICH
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-06-13
FDA-cleared K182901
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-07-05
FDA-cleared K182875
DeepCT
Deep01 Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-07-10
FDA-cleared K183271
AI-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2019-07-26
FDA-cleared K191262
aBSI
EXINI Diagnostics AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-08-05
FDA-cleared K183489
D2P
3D Systems, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-08-29
FDA-cleared K183268
AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2019-09-10
FDA-cleared K192304
SIS Software Version 3.6.0
Surgical Information Sciences, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-09-13
FDA-cleared K190868
Cleerly Labs
Cleerly Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-11-05
FDA-cleared K192109
KOALA
IB Lab GmbH
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-11-05
FDA-cleared K191026
MEDIP PRO
MEDICALIP Co., Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-11-07
FDA-cleared K192571
NemoScan
Software Nemotec S.L.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-12-11
FDA-cleared K192130
Icobrain
Icometrix NV
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-12-13
FDA-cleared K193170
Deep Learning Image Reconstruction
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-12-13
FDA-cleared K192763
syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-12-17
FDA-cleared K192383
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-12-20
FDA-cleared K191125
ADAS 3D
Galgo Medical S.L
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-01-15
FDA-cleared K192956
Auto Positioning
GE Hangwei Medical Systems, Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-01-16
FDA-cleared K192828
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-02-13
FDA-cleared K192832
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-02-21
FDA-cleared K192962
icobrain-ctp
Icometrix NV
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-02-28
FDA-cleared K191550
Broncholab
Fluidda Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-03-04
FDA-cleared K193216
syngo.CT Lung CAD
Siemens Medical Solutions, Inc
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2020-03-09
FDA-cleared K193267
Al-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2020-03-16
FDA-cleared K193658
Viz ICH
Viz.ai, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-03-18
FDA-cleared K193281
Hepatic VCAR
GE Medical Systems SCS
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2020-03-20
FDA-cleared K193087
Rapid ICH
iSchemaView Incorporated
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-03-31
FDA-cleared K192167
CuraRad-ICH
CuraCloud Corp.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-04-13
FDA-cleared K193351
NinesAI
Nines, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-04-21
FDA-cleared K192901
HealthVCF
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-05-12
FDA-cleared K201034
Syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-05-14
FDA-cleared K200921
qER
Qure.ai Technologies
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-06-17
FDA-cleared K193298
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-06-19
FDA-cleared K200855
CINA
AVICENNA.AI
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-06-24
FDA-cleared K192880
InferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2020-07-02
FDA-cleared K193073
Deep Recon
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-07-06
FDA-cleared K200941
Rapid LVO
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-07-09
FDA-cleared K192969
Ezra Plexo Software
Ezra AI Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-07-10
FDA-cleared K200990
VIDAvision
VIDA Diagnostics Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-08-07
FDA-cleared K201310
Accipiolx
MaxQ Al Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-08-07
FDA-cleared K201020
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-08-26
FDA-cleared K201103
Xeleris V Processing and Review Systems
GE Healthcare
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-09-25
FDA-cleared K202280
Cleerly Labs v2.0
Cleerly, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-10-02
FDA-cleared K201710
A View LCS
Coreline Soft Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-10-16
FDA-cleared K200750
Neuro.Al Algorithm
TeraRecon, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-11-06
FDA-cleared K193289
FastStroke, CT Perfusion 4D
GE Medical Systems SCS
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-11-12
FDA-cleared K201195
syngo.via MI Workflows, syngo MBF
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-11-18
FDA-cleared K200873
HALO
NICo-Lab B.V.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-11-20
FDA-cleared K203169
Revolution Ascend
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-11-20
FDA-cleared K202487
HealthJOINT
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-12-04
FDA-cleared K201745
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-12-10
FDA-cleared K203042
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-12-10
FDA-cleared K203508
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-12-29
FDA-cleared K202414
BrainInsight
Hyperfine Research, Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-01-07
FDA-cleared K201836
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-01-12
FDA-cleared K193271
uAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-01-15
FDA-cleared K203582
QUIBIM Precision Prostate (qp-Prostate)
QUIBIM S.L.
Image analysis/processing for Prostate using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Prostate
- Decision
- 2021-02-04
FDA-cleared K202212
TruPlan
Circle Cardiovascular Imaging Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-02-19
FDA-cleared K202990
NinesMeasure
Nines, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-02-25
FDA-cleared K203578
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Perimeter Medical Imaging AI, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-02-25
FDA-cleared K203617
MaxFOV 2
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-02
FDA-cleared K202300
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Optellum Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-05
FDA-cleared K203256
Imbio RV/LV Software
Imbio, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-09
FDA-cleared K210209
Viz ICH
Viz.ai, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2021-03-23
FDA-cleared K203225
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-24
FDA-cleared K203258
syngo.CT Lung CAD
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-03-31
FDA-cleared K210071
SIS System (Version 5.1.0)
Surgical Information Sciences, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-31
FDA-cleared K202992
BriefCase, RIB Fractures Triage (RibFx)
Aidoc Medical, Ltd.
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2021-04-14
FDA-cleared K210556
Preview Shoulder
Genesis Software Innovations
Image analysis/processing for Shoulder using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Shoulder
- Decision
- 2021-04-21
FDA-cleared K210237
CINA CHEST
Avicenna.AI
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-05-19
FDA-cleared K210458
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-06-08
FDA-cleared K211459
syngo.via MI WorkFlows, Scenium, syngo MBF
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-06-10
FDA-cleared K202718
Qmenta Care Platform Family
Mint Labs, Inc., d/b/a. QMENTA
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-06-16
FDA-cleared K203514
Precise Position
Philips Healthcare (Suzhou) Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-06-17
FDA-cleared K210719
Change Healthcare Anatomical AI
Change Healthcare Canada Company
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-07-20
FDA-cleared K211655
aPROMISE
EXINI Diagnostics AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-07-27
FDA-cleared K212074
ClariCT.AI
ClariPi Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-07-27
FDA-cleared K211222
qER-Quant
Qure.ai Technologies
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-07-30
FDA-cleared K203448
uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-08-11
FDA-cleared K211179
InferRead CT Stroke.AI
Infervision Medical Technology Co., Ltd.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2021-08-12
FDA-cleared K211828
Aquilion Exceed LB
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-09-10
FDA-cleared K210085
HealthCCSng
Zebra Medical Vision Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-09-15
FDA-cleared K212067
Deep Learning Image Reconstruction
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-09-17
FDA-cleared K210807
FlightPlan for Liver
GE Medical Systems SCS
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2021-10-22
FDA-cleared K210831
OnQ Neuro
CorTechs Labs, Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-11-19
FDA-cleared K213096
Al-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-12-06
FDA-cleared K202404
BoneMRI
MRIguidance B.V
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2021-12-22
FDA-cleared K211443
AIBOLIT 3D+
AIbolit Technologies, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-01-07
FDA-cleared K210760
Precise Image
Philips Medical Systems Nederland, B.V.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-01-14
FDA-cleared K214019
syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-01-20
FDA-cleared K203260
syngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-01-28
FDA-cleared K213938
Revolution Ascend
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-02-04
FDA-cleared K213165
Rapid
iSchema View Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-02-08
FDA-cleared K213319
Viz ANEURYSM, Viz ANX
Viz.ai, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-02-18
FDA-cleared K213999
Deep Learning Image Reconstruction
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-02-18
FDA-cleared K213725
CardIQ Suite
GE Medical Systems SCS
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-03-11
FDA-cleared K203744
Arterys MICA
Arterys Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2022-03-14
FDA-cleared K214043
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-03-14
FDA-cleared K213779
Customize
3D-Side SA
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-03-16
FDA-cleared K213721
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-03-21
FDA-cleared K212624
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-04
FDA-cleared K203783
ClariPulmo
ClariPi Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-06
FDA-cleared K213944
HealthOST
NanoxAI Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-22
FDA-cleared K212441
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-27
FDA-cleared K220590
aPROMISE X
EXINI Diagnostics AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-29
FDA-cleared K220499
Rapid PE Triage and Notification (PETN)
iSchemaView Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-05-17
FDA-cleared K221219
syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-05-17
FDA-cleared K221240
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-05-17
FDA-cleared K221248
Rapid LVO
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-05-31
FDA-cleared K221314
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-06-03
FDA-cleared K213504
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-06-16
FDA-cleared K221463
ElucidVivo A.3
Elucid Bioimaging Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-06-17
FDA-cleared K220497
CoLumbo
Smart Soft Healthcare AD
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-06-23
FDA-cleared K221727
syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-13
FDA-cleared K220815
BrainInsight
Hyperfine, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-19
FDA-cleared K220624
AI4CMR v1.0
AI4MedImaging Medical Solutions S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-22
FDA-cleared K220439
Viz SDH
Viz.ai, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-25
FDA-cleared K213998
cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-28
FDA-cleared K213760
ABMD Software
HeartLung Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-29
FDA-cleared K220961
Deep Learning Image Reconstruction
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-29
FDA-cleared K221432
Customize
3D-Side SA
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-08-03
FDA-cleared K213713
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2022-08-11
FDA-cleared K220349
TeraRecon Neuro
TeraRecon, Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-08-12
FDA-cleared K222172
MI View&GO
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-08-19
FDA-cleared K222277
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-08-26
FDA-cleared K221100
Viz RV/LV
Viz.ai, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-08-29
FDA-cleared K220986
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-09-12
FDA-cleared K221456
Rapid ICH
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-09-12
FDA-cleared K222329
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-09-28
FDA-cleared K211611
QIR Suite
CASIS Cardiac Simulation & Imaging Software
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-09-30
FDA-cleared K220709
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-10-07
FDA-cleared K222361
AI-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2022-10-20
FDA-cleared K223042
Viz LVO ContaCT
Viz.ai, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-10-21
FDA-cleared K221762
BoneMRI v1.4
MRlguidance B.V.
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2022-11-16
FDA-cleared K221330
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-11-18
FDA-cleared K223032
SIS System (Version 5.6.0)
Surgical Information Sciences, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-11-21
FDA-cleared K221716
CINA
AVICENNA.AI
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-11-22
FDA-cleared K222692
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-12-05
FDA-cleared K223268
BrainInsight
Hyperfine, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-12-16
FDA-cleared K223311
Philips CT 3500
Philips Healthcare (Suzhou) Co., Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-12-22
FDA-cleared K214036
AVIEW
Coreline Soft Co.,Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-12-23
FDA-cleared K222458
AIBOLIT 3D+
Aibolit Technologies, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-01-12
FDA-cleared K222593
TruPlan Computed Tomography (CT) Imaging Software
Circle Cardiovascular Imaging, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-01-18
FDA-cleared K222406
Clarius AI
Clarius Mobile Health Corp.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-01-23
FDA-cleared K223396
Rapid RV/LV
iSchema View Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-02-01
FDA-cleared K230020
BriefCase
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-02-01
FDA-cleared K223028
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-02-16
FDA-cleared K230197
BoneMRI v1.6
MRIguidance B.V.
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2023-02-22
FDA-cleared K221592
AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2023-02-24
FDA-cleared K221680
Xeleris V Processing and Review System
GE Healthcare
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-01
FDA-cleared K222884
Rapid NCCT Stroke
iSchemaView, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-03-02
FDA-cleared K222819
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-03
FDA-cleared K223726
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-07
FDA-cleared K223514
Spectral Bone Marrow
GE Medical Systems, LLC
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2023-03-09
FDA-cleared K223443
Viz AAA
Viz. ai, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-03-17
FDA-cleared K213272
Formus Hip
Formus Labs, Ltd
Image analysis/processing for Hip using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Hip
- Decision
- 2023-03-31
FDA-cleared K223240
Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-04-03
FDA-cleared K222360
AI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2023-04-06
FDA-cleared K213986
CerebralGo Plus
Yukun (Beijing) Technology Co., Ltd
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-04-13
FDA-cleared K230807
Deep Learning Image Reconstruction
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-04-20
FDA-cleared K222676
Ceevra Reveal 3
Ceevra, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-04-25
FDA-cleared K230223
iCAC Device
Bunkerhill, Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-04-25
FDA-cleared K230977
SIS System
Surgical Information Sciences, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-05-02
FDA-cleared K212758
Autoplaque
Cedars-Sinai Medical Center: AIM
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-05-19
FDA-cleared K223855
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
FEops nv
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2023-06-06
FDA-cleared K230112
CAC Software
Imbio, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-06-13
FDA-cleared K222745
Axial3D Insight
Axial Medical Printing Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-07-03
FDA-cleared K223424
Spine Auto Views
GE Medical Systems SCS
Image analysis/processing for Spine using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2023-07-13
FDA-cleared K231757
Ez3D-i /E3
Ewoosoft Co., Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-07-14
FDA-cleared K231157
syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2023-07-19
FDA-cleared K230074
Rapid Aneurysm Triage and Notification
iSchemaView Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-07-27
FDA-cleared K231195
Brainomix 360 Triage ICH
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-07-27
FDA-cleared K231094
Annalise Enterprise CTB Triage-OH
Annalise-AI Pty Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-08-15
FDA-cleared K223180
AIRAscore
AIRAmed GmbH
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-08-25
FDA-cleared K231281
Aquilion Serve (TSX-307A/1) V1.3
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-09-19
FDA-cleared K231384
Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-09-22
FDA-cleared K231767
Annalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-09-22
FDA-cleared K231837
Brainomix 360 Triage LVO
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-09-28
FDA-cleared K230045
HipCheck
Stryker Corp.
Image analysis/processing for Hip using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Hip
- Decision
- 2023-09-29
FDA-cleared K231025
EFAI NeuroSuite CT ICH Assessment System
Ever Fortune.AI Co., Ltd.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-10-04
FDA-cleared K230220
NeuViz 128 Multi-Slice CT Scanner System
Neusoft Medical Systems Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-10-11
FDA-cleared K230370
SpotLight/SpotLight Duo (with DLIR option)
Arineta Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-10-13
FDA-cleared K232436
Rapid SDH
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-10-25
FDA-cleared K232045
MeVis Liver Suite
MeVis Medical Solutions AG
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2023-10-27
FDA-cleared K232751
BriefCase-Triage
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-10-30
FDA-cleared K230534
BriefCase-Quantification
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-11-08
FDA-cleared K232083
BriefCase-Quantification
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-11-13
FDA-cleared K232841
Axial3D Insight
Axial Medical Printing Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-11-15
FDA-cleared K232496
Brainomix 360 Triage Stroke
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-11-21
FDA-cleared K231631
BriefCase-Quantification
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-11-28
FDA-cleared K232000
syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-11-28
FDA-cleared K233568
Ceevra Reveal 3+
Ceevra, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-12-05
FDA-cleared K233334
Aquilion Serve SP (TSX-307B/1) V1.3
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-12-06
FDA-cleared K223757
Bonelogic
Disior Ltd
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2023-12-08
FDA-cleared K231570
StrokeViewer Perfusion
NICo-Lab B.V.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-12-14
FDA-cleared K231929
iQ-solutions
Sydney Neuroimaging Analysis Centre Pty Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-12-18
FDA-cleared K233176
uOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-12-20
FDA-cleared K231324
DASI Dimensions (V1.0)
DASI Simulations
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-01-08
FDA-cleared K232412
LungQ v3.0.0
Thirona BV
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-01-08
FDA-cleared K233512
Rapid (6.0)
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-01-16
FDA-cleared K232698
NemoScan
Software Nemotec S.L.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-01-18
FDA-cleared K231396
CEPHX- Cephalometric Analysis Software
Orca Dental AI LTD
Image analysis/processing for Head/Neck using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Head/Neck
- Decision
- 2024-01-31
FDA-cleared K232363
Viz HDS, Viz Volume Plus, Viz ICH+
Viz.ai, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2024-02-05
FDA-cleared K233080
HealthFLD
Nano-X AI Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-02-08
FDA-cleared K233749
Revolution Ascend Sliding
GE Hangwei Medical Systems Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-02-22
FDA-cleared K232613
CT Cardiomegaly
Innolitics, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-02-28
FDA-cleared K231690
iCAS-LV
HighRAD Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-03-01
FDA-cleared K233030
BoneMRI
MRIguidance B.V
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2024-03-01
FDA-cleared K233968
CINA-iPE
Avicenna.AI
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-03-13
FDA-cleared K233753
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-03-21
FDA-cleared K232431
syngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2024-03-22
FDA-cleared K233650
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-03-26
FDA-cleared K233657
NAEOTOM Alpha
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-03-28
FDA-cleared K233211
AVIEW CAC
Coreline Soft Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-03-29
FDA-cleared K232835
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-04-02
FDA-cleared K240172
Preview Shoulder
Genesis Software Innovations
Image analysis/processing for Shoulder using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Shoulder
- Decision
- 2024-04-04
FDA-cleared K240291
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.AI, Co., Ltd.
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2024-04-08
FDA-cleared K233698
True Enhance DL
GE Healthcare Japan Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-04-11
FDA-cleared K233582
Rapid
iSchema View Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-04-22
FDA-cleared K232491
CT 5300
Philips Healthcare (Suzhou) Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-05-03
FDA-cleared K233247
Heuron ICH
Heuron Co., Ltd.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2024-05-15
FDA-cleared K241112
BriefCase-Quantification
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-05-15
FDA-cleared K233209
uOmnispace.CT
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-05-17
FDA-cleared K240612
CINA-VCF
Avicenna.AI
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-05-31
FDA-cleared K241038
Cardiac CT Function Software Application
Circle Cardiovascular Imaging
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2024-06-07
FDA-cleared K241083
SIS System
Surgical Information Sciences, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-06-14
FDA-cleared K240353
Hyper Insight - ICH
SK Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2024-07-01
FDA-cleared K234009
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-07-12
FDA-cleared K241727
BriefCase-Triage
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-07-12
FDA-cleared K233731
CardIQ Suite
GE Medical Systems SCS
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-08-01
FDA-cleared K240740
qCT LN Quant
Qure.ai Technologies
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-08-16
FDA-cleared K241440
HealthCCSng
Nano-X AI Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-08-19
FDA-cleared K242275
syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-08-30
FDA-cleared K242300
MI View&GO
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-08-30
FDA-cleared K233998
TRAQinform IQ
AIQ Global, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-09-05
FDA-cleared K240411
uAI Portal
Shanghai United Imaging Intelligence Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-09-06
FDA-cleared K240791
ADAS 3D
Adas3D Medical S.L
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-09-09
FDA-cleared K240942
CINA-CSpine
Avicenna.AI
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-09-12
FDA-cleared K242292
uAI Easy Triage ICH
Shanghai United Imaging Intelligence Co., Ltd.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2024-09-24
FDA-cleared K240369
CAC (gated) Algorithm
BunkerHill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-09-27
FDA-cleared K241480
JBS-LVO
JLK, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2024-09-27
FDA-cleared K240943
LungVision
BodyVision Medical Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-10-01
FDA-cleared K242781
cvi42 Software Application
Circle Cardiovascular Imaging Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-10-15
FDA-cleared K242837
BriefCase-Triage
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-10-18
FDA-cleared K241719
NeuroICH
Neurocareai Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-11-07
FDA-cleared K242203
BriefCase-Quantification
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-11-22
FDA-cleared K242188
ClearRead CT CAC
Riverain Technologies, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-03
FDA-cleared K240926
PeekMed web
Peek Health, S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-06
FDA-cleared K241543
DrAid for Liver Segmentation
VinBrain Joint Stock Company
Image analysis/processing for Liver using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Liver
- Decision
- 2024-12-06
FDA-cleared K241923
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.AI, Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-06
FDA-cleared K242461
IRISeg
Intuitive Surgical Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-10
FDA-cleared K243548
BriefCase-Triage
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-11
FDA-cleared K240793
MSKai
MSKai
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-16
FDA-cleared K242403
Aquilion ONE (TSX-308A/3) V1.5
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-23
FDA-cleared K241350
Clarify DL
GE Medical Systems Israel, Functional Imaging
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-03
FDA-cleared K243363
JLK-ICH
JLK, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-01-03
FDA-cleared K242123
Brainomix 360 e-CTA
Brainomix Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-06
FDA-cleared K241079
uCT 780
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-07
FDA-cleared K241200
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-01-13
FDA-cleared K241166
uCT 550
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-14
FDA-cleared K243350
Rapid Neuro3D
iSchemaView, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-22
FDA-cleared K243158
TeraRecon Aorta.CT (1.1.0)
TeraRecon, Inc.
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2025-01-23
FDA-cleared K243229
Bunkerhill AVC
BunkerHill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-27
FDA-cleared K243523
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-02-12
FDA-cleared K243696
AVIEW CAC
Coreline Soft Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-02-14
FDA-cleared K250248
BriefCase-Triage
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-02-14
FDA-cleared K242240
CaRi-Plaque
Caristo Diagnostics Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-02-20
FDA-cleared K241922
Myomics
Phantomics Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-02-28
FDA-cleared K243611
JLK-SDH
JLK, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-03
FDA-cleared K243933
Ceevra Reveal 3+
Ceevra, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-04
FDA-cleared K242338
Cleerly LABS (v2.0)
Cleerly, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-07
FDA-cleared K241725
Better Diagnostics Caries Assist (BDCA) Version 1.0
Better Diagnostics AI Corp
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-11
FDA-cleared K243689
AVIEW
Coreline Soft Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-19
FDA-cleared K250042
PeekMed web
Peek Health, S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-19
FDA-cleared K241961
Vent Creativity Knee v1.0 (Hermes)
Vent Creativity
Image analysis/processing for Knee using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Knee
- Decision
- 2025-03-20
FDA-cleared K243292
brAIn Shoulder Positioning
Avatar Medical
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-03-20
FDA-cleared K242919
V5med Lung AI
V5med Inc.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-03-27
FDA-cleared K243038
Salix Central
Artrya Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-27
FDA-cleared K242166
TribusConnect
TribusMed Beheer BV
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-03-31
FDA-cleared K241984
Hi-D Imaging 4TAVR
Hi-D Imaging AG
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-04-02
FDA-cleared K242295
BunkerHill BMD
BunkerHill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-04-08
FDA-cleared K243145
syngo.CT LVO Detection
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-04-10
FDA-cleared K250650
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-04-15
FDA-cleared K242500
LARALAB
LARALAB GmbH
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-04-16
FDA-cleared K250831
Annalise Enterprise
Annalise-AI
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-04-23
FDA-cleared K243239
Lung AI (LAI001)
Exo Inc
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-04-24
FDA-cleared K242624
Medical Image Post-processing Software (uOmnispace.CT)
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-14
FDA-cleared K240554
InferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-05-16
FDA-cleared K243617
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-16
FDA-cleared K250370
SCENARIA View Phase 5.0
FUJIFILM Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-20
FDA-cleared K250005
Clever One
Ewoosoft Co., Ltd
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-23
FDA-cleared K243378
Rapid MLS
iSchemaview Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-28
FDA-cleared K243863
Opulus Lymphoma Precision
Roche Molecular Systems, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-30
FDA-cleared K251406
BriefCase-Triage
Aidoc Medical, Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-30
FDA-cleared K243810
TraumaCad Neo (1.1)
Brainlab Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-06-04
FDA-cleared K250354
Viz Subdural+, Viz SUBDURAL PLUS
Viz.ai, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-06-10
FDA-cleared K250685
Methinks NCCT Stroke
Methinks Software S.L.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-06-16
FDA-cleared K243672
CardIQ Suite
GE Medical Systems SCS
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-06-18
FDA-cleared K250484
PIUR tUS inside
PIUR Imaging GmbH
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-06-30
FDA-cleared K243779
Bunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2025-07-01
FDA-cleared K251528
syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-07-03
FDA-cleared K251096
PeekMed web
Peek Health, S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-07-14
FDA-cleared K251151
Rapid CTA 360
iSchemaView
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-07-16
FDA-cleared K243681
Neuro Insight V1.0
Olea Medical S.A.S.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-07-23
FDA-cleared K243919
Voxel Dosimetry (00859873006226)
Hermes Medical Solutions AB
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-07-30
FDA-cleared K250941
Revolution Vibe
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-08-01
FDA-cleared K251590
Methinks CTA Stroke
Methinks Software S.L.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-08-20
FDA-cleared K251837
Salix Coronary Plaque (V1.0.0)
Artrya Limited
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-08-20
FDA-cleared K251983
Brainomix 360 Triage Stroke
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-08-26
FDA-cleared K243859
PRAEVAorta®2
Nurea
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-08-29
FDA-cleared K250290
SurgiTwin
Twinsight
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-08-29
FDA-cleared K251533
Rapid Obstructive Hydrocephalus, Rapid OH
iSchemaView Inc.
Image analysis/processing for Head/Neck using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Head/Neck
- Decision
- 2025-09-04
FDA-cleared K251656
Careverse CoronaryDoc (Careverse CoronaryDoc)
Careverse Technology Pte. Ltd.
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-09-04
FDA-cleared K251610
qER-CTA (v1.0)
Qure.ai Technologies
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-09-08
FDA-cleared K251072
Segmentron Viewer
DGNCT, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-09-09
FDA-cleared K244002
AngioWaveNet
Angiowave Imaging, Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2025-09-10
FDA-cleared K250369
Axial3D Insight
Axial Medical Printing Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-09-18
FDA-cleared K251987
Rapid Aortic Measurements
iSchemaView, Inc.
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2025-09-23
FDA-cleared K250766
LungQ 4
Thirona BV
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-10-02
FDA-cleared K250662
Bunkerhill MAC
Bunkerhill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-10-03
FDA-cleared K252214
AIAS Cephalon
Metamorphosis GmbH
Image analysis/processing for Head/Neck using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Head/Neck
- Decision
- 2025-10-07
FDA-cleared K252665
brAIn Shoulder Positioning
Avatar Medical
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-10-20
FDA-cleared K250288
TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2025-10-23
FDA-cleared K251027
cvi42 Coronary Plaque Software Application
Circle Cardiovascular Imaging, Inc.
Image analysis/processing for Heart using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Heart
- Decision
- 2025-10-27
FDA-cleared K250337
AiORTA - Plan
ViTAA Medical Solutions, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-10-30
FDA-cleared K251532
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-11-03
FDA-cleared K253265
BriefCase-Triage
Aidoc Medical , Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-11-06
FDA-cleared K252452
PeekMed web
Peek Health, S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-11-12
FDA-cleared K252366
a2z-Unified-Triage
A2z Radiology Ai, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-11-24
FDA-cleared K250694
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-11-25
FDA-cleared K252217
CT VScore+
Canon Medical Informatics, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-11-28
FDA-cleared K252103
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-12-02
FDA-cleared K251203
AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-12-03
FDA-cleared K251763
IRISeg
Intuitive Surgical, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-12-16
FDA-cleared K252029
AI-CVD
HeartLung Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-12-19
FDA-cleared K252856
PeekMed web
Peek Health, S.A.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-12-22