FDA-cleared K161148
icobrain
Icometrix
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2016-08-09
Use case
MRI workflow radiology AI tools
A buyer-oriented shortlist for mri workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K162830
SIS Software
Surgical Information Sciences, Inc.
SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion,...
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2017-02-14
FDA-cleared K171328
cNeuro cMRI
Combinostics Oy
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2018-01-08
FDA-cleared K173605
iQMR
Medic Vision - Imaging Solutions Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2018-03-08
FDA-cleared K173749
AMRA Profiler
AMRA Medical AB
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2018-12-06
FDA-cleared K182564
Quantib ND
Quantib BV
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2018-12-27
FDA-cleared K183231
SIGNA Premier
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-01-18
FDA-cleared K191688
SubtleMR
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-09-16
FDA-cleared K191493
Ventripoint Medical System Plus (VMS+) 3.0
Ventripoint Diagnostics, Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-10-16
FDA-cleared K191278
RSI-MRI+
MultiModal Imaging Services Corporation (dba HealthLytix)
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-11-19
FDA-cleared K192531
QyScore Software
Qynapse
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-12-13
FDA-cleared K192574
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-03-09
FDA-cleared K193282
SIGNA Premier
GE Healthcare (GE Medical Systems, LLC)
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-04-10
FDA-cleared K193176
uMR 780
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-05-05
FDA-cleared K192601
uWS-MR
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-06-01
FDA-cleared K200232
LVivo Software Application
DiA Imaging Analysis Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-06-23
FDA-cleared K193097
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-07-14
FDA-cleared K200621
Caption Interpretation Automated Ejection Fraction Software
Caption Health
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-07-22
FDA-cleared K202238
SIGNA Artist
GE Healthcare (Tianjin) Company Limited
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-09-04
FDA-cleared K201369
AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd.
Image analysis/processing for Vascular using MRI.
- Modality
- MRI
- Anatomy
- Vascular
- Decision
- 2020-09-16
FDA-cleared K192051
THINQ
CorticoMetrics LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-09-30
FDA-cleared K201615
SIGNA 7.0T
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-10-15
FDA-cleared K193306
PROView
GE Medical Systems SCS
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-11-17
FDA-cleared K193287
CorInsights MRI
ADM Diagnostics, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-11-20
FDA-cleared K201039
HepaFat-AI
Resonance Health Analysis Services Pty Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-12-07
FDA-cleared K202767
Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-01-15
FDA-cleared K210053
LVivo Software Application
DiA Imaging Analysis Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-02-05
FDA-cleared K203182
SubtleMR
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-02-26
FDA-cleared K203323
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-03-04
FDA-cleared K203443
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-03-31
FDA-cleared K211118
SIGNA 7.0T
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-05-13
FDA-cleared K210187
Overjet Dental Assist
Overjet, Inc.
Image analysis/processing for Dental/Maxillofacial using MRI.
- Modality
- MRI
- Anatomy
- Dental/Maxillofacial
- Decision
- 2021-05-19
FDA-cleared K210611
MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-07-01
FDA-cleared K210999
SwiftMR
AIRS Medical Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-10-14
FDA-cleared K212456
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-11-17
FDA-cleared K213305
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-12-01
FDA-cleared K213737
Quantib ND
Quantib B.V.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-01-14
FDA-cleared K211980
SIGNA Prime
GE Healthcare (Tianjin) Company Limited
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-01-16
FDA-cleared K213668
SIGNA Hero
GE Healthcare (GE Medical Systems, LLC)
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-01-20
FDA-cleared K213603
SIGNA Artist Evo
GE Healthcare(Tianjin) Company Limited
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-02-11
FDA-cleared K213693
MAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-02-25
FDA-cleared K210365
Second Opinion
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-03-04
FDA-cleared K220151
MAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-04-01
FDA-cleared K220192
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-04-08
FDA-cleared K220939
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-04-29
FDA-cleared K212519
Overjet Caries Assist
Overjet, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-05-10
FDA-cleared K220589
MAGNETOM Skyra Fit
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-05-13
FDA-cleared K213583
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-05-16
FDA-cleared K220416
SwiftMR
AIRS Medical Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-05-25
FDA-cleared K213717
AIR Recon DL
GE Medical Systems,LLC (GE Healthcare)
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-06-08
FDA-cleared K221393
Swoop Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-06-10
FDA-cleared K220575
MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-06-24
FDA-cleared K221923
Swoop Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-07-28
FDA-cleared K221733
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-09-13
FDA-cleared K221738
NS-HGlio
Neosoma Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-09-27
FDA-cleared K220332
uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-10-27
FDA-cleared K223247
Swoop Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-12-06
FDA-cleared K223442
MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-12-23
FDA-cleared K223502
MR Diffusion Perfusion Mismatch V1.0
Olea Medical
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-01-13
FDA-cleared K223439
SIGNA Victor
GE Healthcare (Tianjin) Company Limited
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-02-13
FDA-cleared K222755
uMR 680
Shanghai United Imaging Intelligence Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-02-16
FDA-cleared K230208
Swoop® Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-02-22
FDA-cleared K223343
MAGNETOM Amira; MAGNETOM Sempra
Siemens Medical Solutions USA Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-03-28
FDA-cleared K223458
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Philips Medical Systems Nederland B.V.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-04-06
FDA-cleared K230264
Ezra Flash
Ezra AI, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-04-13
FDA-cleared K230552
MR DWI/FLAIR Measurement V1.0
Olea Medical
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-04-26
FDA-cleared K220437
Neurophet AQUA
NEUROPHET, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-05-10
FDA-cleared K223623
SubtleMR (2.3.x)
Subtle Medical Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-05-11
FDA-cleared K223523
Sonic DL
GE Medical Systems,LLC (GE Healthcare)
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-05-30
FDA-cleared K231459
HepaFatSmart (V2.0.0)
Resonance Health Analysis Services Pty Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-06-20
FDA-cleared K223426
ECHELON Synergy MRI system
FUJIFILM Healthcare Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-07-13
FDA-cleared K230150
OptimMRI
RebrAIn, SAS
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-07-21
FDA-cleared K230913
ANDI
Imeka Solutions, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-07-25
FDA-cleared K230355
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-08-30
FDA-cleared K232482
MAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-09-06
FDA-cleared K220034
NEUROShield
In-Med Prognostics L3C
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-09-14
FDA-cleared K223659
Jazz
AI Medical AG
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-09-22
FDA-cleared K231398
VUNO Med-DeepBrain
VUNO Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-10-04
FDA-cleared K232760
Swoop® Portable MR Imaging System®
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-10-06
FDA-cleared K231560
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-10-23
FDA-cleared K230854
SwiftMR
AIRS Medical Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-10-27
FDA-cleared K231617
MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-11-09
FDA-cleared K232494
MAGNETOM Avanto fit; MAGNETOM Skyra fit
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-11-14
FDA-cleared K232661
Myocardial Strain Software Application
Circle Cardiovascular Imaging
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-12-07
FDA-cleared K231587
MAGNETOM Cima.X
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-12-18
FDA-cleared K232535
MAGNETOM Sola; MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-12-22
FDA-cleared K233728
SIGNA Champion
GE Healthcare (Tianjin) Company Limited
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-01-19
FDA-cleared K232765
MAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-02-29
FDA-cleared K232322
MAGNETOM Terra; MAGNETOM Terra.X
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-03-22
FDA-cleared K240540
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-03-22
FDA-cleared K240744
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-10
FDA-cleared K240238
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-12
FDA-cleared K233186
uOmnispace.MR
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-17
FDA-cleared K233673
uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-26
FDA-cleared K233687
ECHELON Synergy V10.0
Fujifilm Healthcare Americas Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-05-03
FDA-cleared K233925
Relu Creator
Relu BV
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-06-13
FDA-cleared K241329
SubtleSYNTH (1.x)
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-07-11
FDA-cleared K240944
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-07-16
FDA-cleared K241121
MICSI-RMT
Microstructure Imaging, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-07-17
FDA-cleared K234141
AISAP Cardio V1.0
Aisap
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-01
FDA-cleared K242054
OptimMRI (v2)
Rebrain, SAS
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-12
FDA-cleared K241429
ECHELON Synergy MRI System
FUJIFILM Healthcare Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-13
FDA-cleared K241211
CoLumbo
Smart Soft Healthcare
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-15
FDA-cleared K241496
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-20
FDA-cleared K240290
AiMIFY (1.x)
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-21
FDA-cleared K241098
NeuroQuant
CorTechs Labs, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-08-22
FDA-cleared K241280
Constellation (CON-001)
Q Bio, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-09-12
FDA-cleared K241331
MuscleView
Springbok, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-10-01
FDA-cleared K241242
SIGNA MAGNUS
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-10-17
FDA-cleared K243209
nordicMEDiVA
NordicNeurolab AS
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-10-22
FDA-cleared K242215
Neurophet AQUA (V3.1)
Neurophet, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-10-25
FDA-cleared K243189
TumorSight Viz
SimBioSys, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-10-25
FDA-cleared K242062
1CMR Pro
Mycardium AI Limited
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-11-15
FDA-cleared K240645
Sonix Health
Ontact Health Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-11-27
FDA-cleared K240680
CDM Insights
Oxford Brain Diagnostics Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-12-06
FDA-cleared K242334
Ezra Flash
Ezra AI, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-01-02
FDA-cleared K243335
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-01-07
FDA-cleared K242522
Second Opinion CC
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-01-16
FDA-cleared K242825
Prenuvo Body Composition
Prenuvo
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-01-17
FDA-cleared K243250
SubtleHD (1.x)
Subtle Medical, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-02-12
FDA-cleared K241222
Ventripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-02-26
FDA-cleared K250379
SIGNA Prime Elite
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-03-17
FDA-cleared K243831
Rayvolve LN
AZmed
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-03-26
FDA-cleared K241982
DeepFoqus (DeepFoqus-Accelerate)
Foqus Technologies Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-04-04
FDA-cleared K250416
GBrain MRI
Galileo CDS, Inc
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-04-11
FDA-cleared K243893
Second Opinion® Pediatric
Pearl, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-05
FDA-cleared K243230
Second Opinion® BLE
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-09
FDA-cleared K243122
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-21
FDA-cleared K251276
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-21
FDA-cleared K243989
Second Opinion® 3D
Pearl, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-23
FDA-cleared K250367
CoLumboX
Smart Soft Healthcare AD
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-28
FDA-cleared K250236
Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-30
FDA-cleared K251397
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Philips Medical Systems Nederland B.V.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-04
FDA-cleared K243667
Sonic DL
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-05
FDA-cleared K251009
Cirrus Resting State fMRI Software
Sora Neuroscience, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-06
FDA-cleared K243234
Second Opinion® CS
Pearl Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-12
FDA-cleared K250436
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Siemens Shenzhen Magnetic Resonance , Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-16
FDA-cleared K250443
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-16
FDA-cleared K251766
TumorSight Viz
SimBioSys, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-08
FDA-cleared K243397
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-16
FDA-cleared K243547
uMR Ultra
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-17
FDA-cleared K250686
GyriCalc (Version 1.0.0)
NeuroSpectrum Insights Corp.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-22
FDA-cleared K250901
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-22
FDA-cleared K250246
uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-08-05
FDA-cleared K251029
Vista OS, Vista AI Scan, RTHawk
Vista AI, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-08-21
FDA-cleared K252362
GBrain MRI
Galileo CDS, Inc
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-08-22
FDA-cleared K251682
MuscleView 2.0
Springbok, Inc. (dba Springbok Analytics)
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-09
FDA-cleared K251399
SIGNA Sprint
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-11
FDA-cleared K251386
ECHELON Synergy
Fujifilm Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-17
FDA-cleared K252371
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-25
FDA-cleared K252298
ANDI 2.0
Imeka Solutions, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-10-22
FDA-cleared K250525
Second Opinion® Panoramic
Pearl, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-11-14
FDA-cleared K251822
MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-11-20
FDA-cleared K253489
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-12
FDA-cleared K252670
Alzevita
TOPIA MEDTECH LIMITED
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-19
FDA-cleared K252838
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-19
FDA-cleared K252379
AIR Recon DL
Ge Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-23