CT/CTA workflow radiology AI tools

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

CT/CTA workflow

FDA-cleared K180161

Viz CTP

Viz.ai, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-04-20

CT/CTA workflow

FDA-cleared K172983

HealthCCS

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-06-13

CT/CTA workflow

FDA-cleared K173444

Quantitative Total Extensible Imaging (QTxI)

AIQ Solutions, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-07-23

CT/CTA workflow

FDA-cleared K180647

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-08-01

CT/CTA workflow

FDA-cleared K182177

Accipiolx

MaxQ-Al Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-10-26

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K181939

icobrain

icometrix NV

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-11-06

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K183012

vascuCAP

Elucid Bioimaging Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-12-21

CT/CTA workflow

FDA-cleared K182130

iSchemaView RAPID

iSchemaView, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-12-27

CT/CTA workflow

FDA-cleared K183133

MRCP+ v1.0

Perspectum Diagnostics Ltd

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-01-09

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K183202

Deep Learning Image Reconstruction

GE Medical Systems, LLC.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-04-12

CT/CTA workflow

FDA-cleared K190072

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-04-15

CT/CTA workflow

FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-05-31

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-06-13

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K182875

DeepCT

Deep01 Limited

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-07-10

CT/CTA workflow

FDA-cleared K191262

aBSI

EXINI Diagnostics AB

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-08-05

CT/CTA workflow

FDA-cleared K183489

D2P

3D Systems, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-08-29

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K190868

Cleerly Labs

Cleerly Inc

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-11-05

CT/CTA workflow

FDA-cleared K192109

KOALA

IB Lab GmbH

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-11-05

CT/CTA workflow

FDA-cleared K191026

MEDIP PRO

MEDICALIP Co., Ltd

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-11-07

CT/CTA workflow

FDA-cleared K192571

NemoScan

Software Nemotec S.L.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-11

CT/CTA workflow

FDA-cleared K192130

Icobrain

Icometrix NV

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-13

CT/CTA workflow

FDA-cleared K193170

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-13

CT/CTA workflow

FDA-cleared K192763

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-17

CT/CTA workflow

FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-20

CT/CTA workflow

FDA-cleared K191125

ADAS 3D

Galgo Medical S.L

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-01-15

CT/CTA workflow

FDA-cleared K192956

Auto Positioning

GE Hangwei Medical Systems, Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-01-16

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K192962

icobrain-ctp

Icometrix NV

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-02-28

CT/CTA workflow

FDA-cleared K191550

Broncholab

Fluidda Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-03-04

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K193087

Rapid ICH

iSchemaView Incorporated

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-03-31

CT/CTA workflow

FDA-cleared K192167

CuraRad-ICH

CuraCloud Corp.

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-04-13

CT/CTA workflow

FDA-cleared K193351

NinesAI

Nines, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-04-21

CT/CTA workflow

FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-05-12

CT/CTA workflow

FDA-cleared K201034

Syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-05-14

CT/CTA workflow

FDA-cleared K200921

qER

Qure.ai Technologies

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-17

CT/CTA workflow

FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-19

CT/CTA workflow

FDA-cleared K200855

CINA

AVICENNA.AI

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-24

CT/CTA workflow

FDA-cleared K193073

Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-07-06

CT/CTA workflow

FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-07-09

CT/CTA workflow

FDA-cleared K192969

Ezra Plexo Software

Ezra AI Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-07-10

CT/CTA workflow

FDA-cleared K200990

VIDAvision

VIDA Diagnostics Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-08-07

CT/CTA workflow

FDA-cleared K201310

Accipiolx

MaxQ Al Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-08-07

CT/CTA workflow

FDA-cleared K201020

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-08-26

CT/CTA workflow

FDA-cleared K201103

Xeleris V Processing and Review Systems

GE Healthcare

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-09-25

CT/CTA workflow

FDA-cleared K202280

Cleerly Labs v2.0

Cleerly, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-10-02

CT/CTA workflow

FDA-cleared K201710

A View LCS

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-10-16

CT/CTA workflow

FDA-cleared K200750

Neuro.Al Algorithm

TeraRecon, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-11-06

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K200873

HALO

NICo-Lab B.V.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-11-20

CT/CTA workflow

FDA-cleared K203169

Revolution Ascend

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-11-20

CT/CTA workflow

FDA-cleared K202487

HealthJOINT

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-12-04

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K203508

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-12-29

CT/CTA workflow

FDA-cleared K202414

BrainInsight

Hyperfine Research, Inc

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-01-07

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K202212

TruPlan

Circle Cardiovascular Imaging Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-02-19

CT/CTA workflow

FDA-cleared K202990

NinesMeasure

Nines, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-02-25

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K203617

MaxFOV 2

GE Medical Systems, LLC.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-03-02

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K203256

Imbio RV/LV Software

Imbio, LLC

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-03-09

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K203514

Precise Position

Philips Healthcare (Suzhou) Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-06-17

CT/CTA workflow

FDA-cleared K210719

Change Healthcare Anatomical AI

Change Healthcare Canada Company

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-07-20

CT/CTA workflow

FDA-cleared K211655

aPROMISE

EXINI Diagnostics AB

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-07-27

CT/CTA workflow

FDA-cleared K212074

ClariCT.AI

ClariPi Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-07-27

CT/CTA workflow

FDA-cleared K211222

qER-Quant

Qure.ai Technologies

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-07-30

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K211828

Aquilion Exceed LB

Canon Medical Systems Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-09-10

CT/CTA workflow

FDA-cleared K210085

HealthCCSng

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-09-15

CT/CTA workflow

FDA-cleared K212067

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-09-17

CT/CTA workflow

FDA-cleared K210831

OnQ Neuro

CorTechs Labs, Inc

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-11-19

CT/CTA workflow

FDA-cleared K211443

AIBOLIT 3D+

AIbolit Technologies, LLC

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-01-07

CT/CTA workflow

FDA-cleared K210760

Precise Image

Philips Medical Systems Nederland, B.V.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-01-14

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K213938

Revolution Ascend

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-02-04

CT/CTA workflow

FDA-cleared K213165

Rapid

iSchema View Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-02-08

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K213999

Deep Learning Image Reconstruction

GE Medical Systems, LLC.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-02-18

CT/CTA workflow

FDA-cleared K213725

CardIQ Suite

GE Medical Systems SCS

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-03-11

CT/CTA workflow

FDA-cleared K203744

Arterys MICA

Arterys Inc.

Image analysis/processing for Vascular using CT/CTA.

Modality: CT/CTA
Anatomy: Vascular
Decision: 2022-03-14

CT/CTA workflow

FDA-cleared K214043

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-03-14

CT/CTA workflow

FDA-cleared K213779

Customize

3D-Side SA

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-03-16

CT/CTA workflow

FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-03-21

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K203783

ClariPulmo

ClariPi Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-04-06

CT/CTA workflow

FDA-cleared K213944

HealthOST

NanoxAI Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-04-22

CT/CTA workflow

FDA-cleared K212441

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-04-27

CT/CTA workflow

FDA-cleared K220590

aPROMISE X

EXINI Diagnostics AB

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-04-29

CT/CTA workflow

FDA-cleared K220499

Rapid PE Triage and Notification (PETN)

iSchemaView Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

CT/CTA workflow

FDA-cleared K221219

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

CT/CTA workflow

FDA-cleared K221240

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

CT/CTA workflow

FDA-cleared K221248

Rapid LVO

iSchemaView Inc.

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-05-31

CT/CTA workflow

FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-06-03

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K221463

ElucidVivo A.3

Elucid Bioimaging Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-06-17

CT/CTA workflow

FDA-cleared K220497

CoLumbo

Smart Soft Healthcare AD

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-06-23

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K220815

BrainInsight

Hyperfine, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-19

CT/CTA workflow

FDA-cleared K220624

AI4CMR v1.0

AI4MedImaging Medical Solutions S.A.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-22

CT/CTA workflow

FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-25

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K213760

ABMD Software

HeartLung Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-29

CT/CTA workflow

FDA-cleared K220961

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-29

CT/CTA workflow

FDA-cleared K221432

Customize

3D-Side SA

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-03

CT/CTA workflow

FDA-cleared K220349

TeraRecon Neuro

TeraRecon, Inc

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-12

CT/CTA workflow

FDA-cleared K222172

MI View&GO

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-19

CT/CTA workflow

FDA-cleared K222277

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-26

CT/CTA workflow

FDA-cleared K221100

Viz RV/LV

Viz.ai, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-29

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-09-12

CT/CTA workflow

FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-09-28

CT/CTA workflow

FDA-cleared K211611

QIR Suite

CASIS Cardiac Simulation & Imaging Software

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-09-30

CT/CTA workflow

FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-10-07

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K221330

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-11-18

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K221716

CINA

AVICENNA.AI

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-11-22

CT/CTA workflow

FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-12-05

CT/CTA workflow

FDA-cleared K223268

BrainInsight

Hyperfine, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-12-16

CT/CTA workflow

FDA-cleared K223311

Philips CT 3500

Philips Healthcare (Suzhou) Co., Ltd

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-12-22

CT/CTA workflow

FDA-cleared K214036

AVIEW

Coreline Soft Co.,Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-12-23

CT/CTA workflow

FDA-cleared K222458

AIBOLIT 3D+

Aibolit Technologies, LLC

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-01-12

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K222406

Clarius AI

Clarius Mobile Health Corp.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-01-23

CT/CTA workflow

FDA-cleared K223396

Rapid RV/LV

iSchema View Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-02-01

CT/CTA workflow

FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-02-01

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K221680

Xeleris V Processing and Review System

GE Healthcare

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-03-01

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-03-17

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K230807

Deep Learning Image Reconstruction

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-04-20

CT/CTA workflow

FDA-cleared K222676

Ceevra Reveal 3

Ceevra, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-04-25

CT/CTA workflow

FDA-cleared K230223

iCAC Device

Bunkerhill, Inc

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-04-25

CT/CTA workflow

FDA-cleared K230977

SIS System

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-05-02

CT/CTA workflow

FDA-cleared K212758

Autoplaque

Cedars-Sinai Medical Center: AIM

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-05-19

CT/CTA workflow

FDA-cleared K230112

CAC Software

Imbio, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-06-13

CT/CTA workflow

FDA-cleared K222745

Axial3D Insight

Axial Medical Printing Limited

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-07-03

CT/CTA workflow

FDA-cleared K231757

Ez3D-i /E3

Ewoosoft Co., Ltd

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-07-14

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K223180

AIRAscore

AIRAmed GmbH

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-08-25

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K230045

HipCheck

Stryker Corp.

Image analysis/processing for Hip using CT/CTA.

Modality: CT/CTA
Anatomy: Hip
Decision: 2023-09-29

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K230370

SpotLight/SpotLight Duo (with DLIR option)

Arineta Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-13

CT/CTA workflow

FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-25

CT/CTA workflow

FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-30

CT/CTA workflow

FDA-cleared K230534

BriefCase-Quantification

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-11-08

CT/CTA workflow

FDA-cleared K232083

BriefCase-Quantification

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-11-13

CT/CTA workflow

FDA-cleared K232841

Axial3D Insight

Axial Medical Printing Limited

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-11-15

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K231631

BriefCase-Quantification

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-11-28

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K233568

Ceevra Reveal 3+

Ceevra, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-12-05

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K231929

iQ-solutions

Sydney Neuroimaging Analysis Centre Pty Ltd

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-12-18

CT/CTA workflow

FDA-cleared K233176

uOmnispace.MI

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-12-20

CT/CTA workflow

FDA-cleared K231324

DASI Dimensions (V1.0)

DASI Simulations

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-01-08

CT/CTA workflow

FDA-cleared K233512

Rapid (6.0)

iSchemaView, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-01-16

CT/CTA workflow

FDA-cleared K232698

NemoScan

Software Nemotec S.L.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-01-18

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K233080

HealthFLD

Nano-X AI Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-02-08

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K232613

CT Cardiomegaly

Innolitics, LLC

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-02-28

CT/CTA workflow

FDA-cleared K231690

iCAS-LV

HighRAD Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-03-01

CT/CTA workflow

FDA-cleared K233968

CINA-iPE

Avicenna.AI

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-03-13

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K233657

NAEOTOM Alpha

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-03-28

CT/CTA workflow

FDA-cleared K233211

AVIEW CAC

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-03-29

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K233698

True Enhance DL

GE Healthcare Japan Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-04-11

CT/CTA workflow

FDA-cleared K233582

Rapid

iSchema View Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-04-22

CT/CTA workflow

FDA-cleared K232491

CT 5300

Philips Healthcare (Suzhou) Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-05-03

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K241112

BriefCase-Quantification

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-05-15

CT/CTA workflow

FDA-cleared K233209

uOmnispace.CT

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-05-17

CT/CTA workflow

FDA-cleared K240612

CINA-VCF

Avicenna.AI

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-05-31

CT/CTA workflow

FDA-cleared K241083

SIS System

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-06-14

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K241727

BriefCase-Triage

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-07-12

CT/CTA workflow

FDA-cleared K233731

CardIQ Suite

GE Medical Systems SCS

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-08-01

CT/CTA workflow

FDA-cleared K240740

qCT LN Quant

Qure.ai Technologies

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-08-16

CT/CTA workflow

FDA-cleared K241440

HealthCCSng

Nano-X AI Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-08-19

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K242300

MI View&GO

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-08-30

CT/CTA workflow

FDA-cleared K233998

TRAQinform IQ

AIQ Global, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-09-05

CT/CTA workflow

FDA-cleared K240411

uAI Portal

Shanghai United Imaging Intelligence Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-09-06

CT/CTA workflow

FDA-cleared K240791

ADAS 3D

Adas3D Medical S.L

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-09-09

CT/CTA workflow

FDA-cleared K240942

CINA-CSpine

Avicenna.AI

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-09-12

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K240369

CAC (gated) Algorithm

BunkerHill Health

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-09-27

CT/CTA workflow

FDA-cleared K241480

JBS-LVO

JLK, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-09-27

CT/CTA workflow

FDA-cleared K242781

cvi42 Software Application

Circle Cardiovascular Imaging Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-10-15

CT/CTA workflow

FDA-cleared K242837

BriefCase-Triage

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-10-18

CT/CTA workflow

FDA-cleared K241719

NeuroICH

Neurocareai Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-11-07

CT/CTA workflow

FDA-cleared K242203

BriefCase-Quantification

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-11-22

CT/CTA workflow

FDA-cleared K242188

ClearRead CT CAC

Riverain Technologies, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-03

CT/CTA workflow

FDA-cleared K240926

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-06

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K242461

IRISeg

Intuitive Surgical Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-10

CT/CTA workflow

FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-11

CT/CTA workflow

FDA-cleared K240793

MSKai

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-16

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K241350

Clarify DL

GE Medical Systems Israel, Functional Imaging

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-01-03

CT/CTA workflow

FDA-cleared K243363

JLK-ICH

JLK, Inc.

Image analysis/processing for Brain using CT/CTA.

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-01-03

CT/CTA workflow

FDA-cleared K242123

Brainomix 360 e-CTA

Brainomix Limited

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-01-06

CT/CTA workflow

FDA-cleared K241079

uCT 780

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-01-07

CT/CTA workflow

FDA-cleared K241166

uCT 550

Shanghai United Imaging Healthcare Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-01-14

CT/CTA workflow

FDA-cleared K243350

Rapid Neuro3D

iSchemaView, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-01-22

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243229

Bunkerhill AVC

BunkerHill Health

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-01-27

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243696

AVIEW CAC

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-02-14

CT/CTA workflow

FDA-cleared K250248

BriefCase-Triage

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-02-14

CT/CTA workflow

FDA-cleared K242240

CaRi-Plaque

Caristo Diagnostics Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-02-20

CT/CTA workflow

FDA-cleared K241922

Myomics

Phantomics Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-02-28

CT/CTA workflow

FDA-cleared K243611

JLK-SDH

JLK, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-03

CT/CTA workflow

FDA-cleared K243933

Ceevra Reveal 3+

Ceevra, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-04

CT/CTA workflow

FDA-cleared K242338

Cleerly LABS (v2.0)

Cleerly, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-07

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243689

AVIEW

Coreline Soft Co., Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-19

CT/CTA workflow

FDA-cleared K250042

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-19

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243038

Salix Central

Artrya Limited

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-27

CT/CTA workflow

FDA-cleared K242166

TribusConnect

TribusMed Beheer BV

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-31

CT/CTA workflow

FDA-cleared K241984

Hi-D Imaging 4TAVR

Hi-D Imaging AG

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-04-02

CT/CTA workflow

FDA-cleared K242295

BunkerHill BMD

BunkerHill Health

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-04-08

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K242500

LARALAB

LARALAB GmbH

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-04-16

CT/CTA workflow

FDA-cleared K250831

Annalise Enterprise

Annalise-AI

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-04-23

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K250370

SCENARIA View Phase 5.0

FUJIFILM Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-20

CT/CTA workflow

FDA-cleared K250005

Clever One

Ewoosoft Co., Ltd

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-23

CT/CTA workflow

FDA-cleared K243378

Rapid MLS

iSchemaview Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-28

CT/CTA workflow

FDA-cleared K243863

Opulus Lymphoma Precision

Roche Molecular Systems, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-30

CT/CTA workflow

FDA-cleared K251406

BriefCase-Triage

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-30

CT/CTA workflow

FDA-cleared K243810

TraumaCad Neo (1.1)

Brainlab Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-06-04

CT/CTA workflow

FDA-cleared K250354

Viz Subdural+, Viz SUBDURAL PLUS

Viz.ai, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-06-10

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243672

CardIQ Suite

GE Medical Systems SCS

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-06-18

CT/CTA workflow

FDA-cleared K250484

PIUR tUS inside

PIUR Imaging GmbH

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-06-30

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K251096

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-07-14

CT/CTA workflow

FDA-cleared K251151

Rapid CTA 360

iSchemaView

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-07-16

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243919

Voxel Dosimetry (00859873006226)

Hermes Medical Solutions AB

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-07-30

CT/CTA workflow

FDA-cleared K250941

Revolution Vibe

GE Medical Systems, LLC

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-08-01

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K243859

PRAEVAorta®2

Nurea

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-08-29

CT/CTA workflow

FDA-cleared K250290

SurgiTwin

Twinsight

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-08-29

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-09-08

CT/CTA workflow

FDA-cleared K251072

Segmentron Viewer

DGNCT, LLC

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-09-09

CT/CTA workflow

FDA-cleared K244002

AngioWaveNet

Angiowave Imaging, Inc.

Image analysis/processing for Vascular using CT/CTA.

Modality: CT/CTA
Anatomy: Vascular
Decision: 2025-09-10

CT/CTA workflow

FDA-cleared K250369

Axial3D Insight

Axial Medical Printing Limited

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-09-18

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K250662

Bunkerhill MAC

Bunkerhill Health

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-10-03

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K250337

AiORTA - Plan

ViTAA Medical Solutions, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-10-30

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K253265

BriefCase-Triage

Aidoc Medical , Ltd.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-06

CT/CTA workflow

FDA-cleared K252452

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-12

CT/CTA workflow

FDA-cleared K252366

a2z-Unified-Triage

A2z Radiology Ai, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-24

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K252217

CT VScore+

Canon Medical Informatics, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-28

CT/CTA workflow

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

CT/CTA workflow

FDA-cleared K251763

IRISeg

Intuitive Surgical, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-12-16

CT/CTA workflow

FDA-cleared K252029

AI-CVD

HeartLung Corporation

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-12-19

CT/CTA workflow

FDA-cleared K252856

PeekMed web

Peek Health, S.A.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-12-22

CT/CTA workflow