MRI radiology AI tools | FDA-cleared directory

FDA-cleared K253625

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-03-27

MRI workflow

FDA-cleared K260746

S-scan Open (100001800)

Esaote, S.p.A.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-03-27

MRI workflow

FDA-cleared K253775

SwiftMR

Airs Medical, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2026-03-26

MRI workflow

FDA-cleared K253413

LiverMultiScan (v6.0)

Perspectum, Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Liver
Decision: 2026-03-09

Oncology quantification

FDA-cleared K251901

Magnifico Open (100009900)

Esaote, S.p.A.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-03-05

MRI workflow

FDA-cleared K253648

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

Philips Medical Systems Nederland B.V.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-02-23

MRI workflow

FDA-cleared K260265

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance, Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-02-23

MRI workflow

FDA-cleared K252084

AI4CMR v2.0

Ai4medimaging Medical Solutions S.A.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2026-02-11

MRI workflow

FDA-cleared K253780

SIGNA™ Bolt

Ge Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-02-06

MRI workflow

FDA-cleared K253779

SIGNA™ Sprint Select

Ge Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2026-02-05

MRI workflow

FDA-cleared K253057

AI-Rad Companion Brain MR

Siemens Healthcare GmbH

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2026-01-22

Neuro MRI

FDA-cleared K252379

AIR Recon DL

Ge Medical Systems, LLC

AIR Recon DL reconstructs compatible GE MR acquisitions to reduce noise and ringing; K252379 adds deep-learning phase correction and phase-corrected AIR Recon DL for...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-12-23

MRI workflow

FDA-cleared K252670

Alzevita

TOPIA MEDTECH LIMITED

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-12-19

MRI workflow

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

The listed MAGNETOM systems with syngo MR XB10 produce cross-sectional images, spectra, and derived physical parameters of the head, body, and extremities for trained-physician...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-12-19

MRI workflow

FDA-cleared K252922

Neosoma Brain Mets

Neosoma, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2025-12-17

Neuro MRI

FDA-cleared K253489

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

Swoop Portable MR Imaging System provides ultra-low-field point-of-care head MRI for all ages and includes deep-learning T1, T2, FLAIR, and DWI reconstruction.

Modality: MRI
Anatomy: Brain
Decision: 2025-12-12

Neuro MRI

FDA-cleared K251822

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance, Ltd.

MAGNETOM Free.Max and Free.Star with syngo MR XA80A are 0.55T MRI systems for broad imaging and compatible interventions; this release adds dentomaxillofacial coil and assist...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-11-20

MRI workflow

FDA-cleared K252298

ANDI 2.0

Imeka Solutions, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-10-22

MRI workflow

FDA-cleared K251527

Brain WMH

Quantib BV

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2025-09-25

Neuro MRI

FDA-cleared K252371

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-09-25

MRI workflow

FDA-cleared K251483

SwiftSight-Brain

AIRS Medical Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2025-09-23

Neuro MRI

FDA-cleared K251386

ECHELON Synergy

Fujifilm Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-09-17

MRI workflow

FDA-cleared K251399

SIGNA™ Sprint

GE Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-09-11

MRI workflow

FDA-cleared K251682

MuscleView 2.0

Springbok, Inc. (dba Springbok Analytics)

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-09-09

MRI workflow

FDA-cleared K252362

GBrain MRI

Galileo CDS, Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2025-08-22

Neuro MRI

FDA-cleared K251029

Vista OS, Vista AI Scan, RTHawk

Vista AI, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-08-21

MRI workflow

FDA-cleared K250246

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-08-05

MRI workflow

FDA-cleared K243681

Neuro Insight V1.0

Olea Medical S.A.S.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2025-07-23

Neuro MRI

FDA-cleared K250686

GyriCalc (Version 1.0.0)

NeuroSpectrum Insights Corp.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-07-22

MRI workflow

FDA-cleared K250901

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-07-22

MRI workflow

FDA-cleared K243547

uMR Ultra

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-07-17

MRI workflow

FDA-cleared K243397

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-07-16

MRI workflow

FDA-cleared K251766

TumorSight Viz

SimBioSys, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-07-08

MRI workflow

FDA-cleared K250436

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance, Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-06-16

MRI workflow

FDA-cleared K250443

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

Siemens Healthcare GmbH

MAGNETOM Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile with syngo MR XA70A produce diagnostic MR images, spectra, and derived physical parameters and add model-specific Deep...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-06-16

MRI workflow

FDA-cleared K251009

Cirrus Resting State fMRI Software

Sora Neuroscience, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-06-06

MRI workflow

FDA-cleared K243667

Sonic DL

GE Medical Systems, LLC

Sonic DL is optional integrated GE MRI reconstruction for supported 2D cardiac cine and 3D fast-spin-echo or gradient-echo acquisitions at 1.5T, 3T, and 7T for all ages and...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-06-05

Cardiac imaging Detection and CADe

FDA-cleared K251397

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

Philips Medical Systems Nederland B.V.

The Philips 1.5T and 3T MRI system family with release R12.3 supports broad diagnostic and interventional imaging and adds SmartSpeed Precise machine-learning reconstruction.

Modality: MRI
Anatomy: Multi-region
Decision: 2025-06-04

MRI workflow

FDA-cleared K250236

Swoop® Portable MR Imaging® System (V2)

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-05-30

MRI workflow

FDA-cleared K243989

Second Opinion® 3D

Pearl, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-05-23

MRI workflow

FDA-cleared K243122

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-05-21

MRI workflow

FDA-cleared K251276

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-05-21

MRI workflow

FDA-cleared K243230

Second Opinion® BLE

Pearl Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-05-09

MRI workflow

FDA-cleared K250416

GBrain MRI

Galileo CDS, Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2025-04-11

Neuro MRI

FDA-cleared K241982

DeepFoqus (DeepFoqus-Accelerate)

Foqus Technologies Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-04-04

MRI workflow

FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-18

Breast imaging Prostate imaging Detection and CADe

FDA-cleared K250379

SIGNA Prime Elite

GE Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-03-17

MRI workflow

FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI is a concurrent reading aid for radiologists interpreting prostate MRI examinations acquired according to the PI-RADS standard, assisting with detection and...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-05

Prostate imaging Detection and CADe

FDA-cleared K241922

Myomics

Phantomics Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-02-28

MRI workflow

FDA-cleared K241222

Ventripoint Medical System Plus (VMS+) 4.0

Ventripoint Diagnostics Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-02-26

MRI workflow

FDA-cleared K242607

ScanDiags Ortho L-Spine MR-Q

ScanDiags AG

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Spine
Decision: 2025-02-21

MSK and bone

FDA-cleared K243250

SubtleHD (1.x)

Subtle Medical, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-02-12

MRI workflow

FDA-cleared K242825

Prenuvo Body Composition

Prenuvo

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-01-17

MRI workflow

FDA-cleared K243335

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2025-01-07

MRI workflow

FDA-cleared K242334

Ezra Flash

Ezra AI, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2025-01-02

MRI workflow

FDA-cleared K240793

MSKai

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-12-16

MRI workflow

FDA-cleared K240680

CDM Insights

Oxford Brain Diagnostics Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-12-06

MRI workflow

FDA-cleared K242062

1CMR Pro

Mycardium AI Limited

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-11-15

MRI workflow

FDA-cleared K240712

icobrain aria

icometrix NV

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: MRI
Anatomy: Brain
Decision: 2024-11-07

MSK and bone Detection and CADe Neuro MRI

FDA-cleared K241312

TeraRecon Cardiac.Chambers.MR (1.0.0)

TeraRecon,Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Heart
Decision: 2024-11-05

Cardiac imaging

FDA-cleared K241108

RemedyLogic AI MRI Lumbar Spine Reader

Remedy Logic Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Spine
Decision: 2024-10-30

MSK and bone

FDA-cleared K242215

Neurophet AQUA (V3.1)

Neurophet, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2024-10-25

Neuro MRI

FDA-cleared K243189

TumorSight Viz

SimBioSys, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-10-25

MRI workflow

FDA-cleared K243209

nordicMEDiVA

NordicNeurolab AS

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-10-22

MRI workflow

FDA-cleared K241242

SIGNA MAGNUS

GE Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-10-17

MRI workflow

FDA-cleared K241331

MuscleView

Springbok, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-10-01

MRI workflow

FDA-cleared K241280

Constellation (CON-001)

Q Bio, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-09-12

MRI workflow

FDA-cleared K241098

NeuroQuant

CorTechs Labs, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2024-08-22

Neuro MRI

FDA-cleared K240290

AiMIFY (1.x)

Subtle Medical, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-08-21

MRI workflow

FDA-cleared K241496

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-08-20

MRI workflow

FDA-cleared K241211

CoLumbo

Smart Soft Healthcare

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-08-15

MRI workflow

FDA-cleared K241429

ECHELON Synergy MRI System

FUJIFILM Healthcare Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-08-13

MRI workflow

FDA-cleared K242054

OptimMRI (v2)

Rebrain, SAS

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-08-12

MRI workflow

FDA-cleared K233822

i2Contour

MRIMath LLC

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-08-08

MRI workflow

FDA-cleared K234141

AISAP Cardio V1.0

Aisap

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality: MRI
Anatomy: N/A
Decision: 2024-08-01

MRI workflow

FDA-cleared K241121

MICSI-RMT

Microstructure Imaging, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-07-17

MRI workflow

FDA-cleared K240944

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-07-16

MRI workflow

FDA-cleared K241329

SubtleSYNTH (1.x)

Subtle Medical, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-07-11

MRI workflow

FDA-cleared K233196

Medihub Prostate

JLK Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Prostate
Decision: 2024-06-21

Prostate imaging

FDA-cleared K233925

Relu Creator

Relu BV

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-06-13

MRI workflow

FDA-cleared K233687

ECHELON Synergy V10.0

Fujifilm Healthcare Americas Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-05-03

MRI workflow

FDA-cleared K233673

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-04-26

MRI workflow

FDA-cleared K233186

uOmnispace.MR

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2024-04-17

MRI workflow

FDA-cleared K240238

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-04-12

MRI workflow

FDA-cleared K240744

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-04-10

MRI workflow

FDA-cleared K232322

MAGNETOM Terra; MAGNETOM Terra.X

Siemens Medical Solutions USA, Inc.

MAGNETOM Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head...

Modality: MRI
Anatomy: Head/Extremities
Decision: 2024-03-22

MRI workflow

FDA-cleared K240540

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-03-22

MRI workflow

FDA-cleared K233030

BoneMRI

MRIguidance B.V

BoneMRI is image-processing software that enhances visualization of pelvic and spinal bone structures in MRI images relative to surrounding soft tissue.

Modality: MRI
Anatomy: Bone
Decision: 2024-03-01

MSK and bone

FDA-cleared K232765

MAGNETOM Cima.X Fit

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-02-29

MRI workflow

FDA-cleared K233728

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2024-01-19

MRI workflow

FDA-cleared K232535

MAGNETOM Sola; MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-12-22

MRI workflow

FDA-cleared K231587

MAGNETOM Cima.X

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-12-18

MRI workflow

FDA-cleared K231929

iQ-solutions

Sydney Neuroimaging Analysis Centre Pty Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2023-12-18

MRI workflow

FDA-cleared K232231

QP-Brain®

Quibim S.L.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2023-12-13

Neuro MRI

FDA-cleared K232661

Myocardial Strain Software Application

Circle Cardiovascular Imaging

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-12-07

MRI workflow

FDA-cleared K232494

MAGNETOM Avanto fit; MAGNETOM Skyra fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an...

Modality: MRI
Anatomy: Multi-region
Decision: 2023-11-14

MRI workflow

FDA-cleared K231617

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-11-09

MRI workflow

FDA-cleared K230854

SwiftMR

AIRS Medical Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-10-27

MRI workflow

FDA-cleared K231560

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Aera, Skyra, Prisma, Prisma fit, Vida, and Lumina with syngo MR XA60A are 1.5T and 3T MRI systems that produce cross-sectional images, spectroscopic images or spectra,...

Modality: MRI
Anatomy: Multi-region
Decision: 2023-10-23

MRI workflow

FDA-cleared K232305

AI-Rad Companion Brain MR

Siemens Medical Solutions U.S.A.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2023-10-23

Neuro MRI

FDA-cleared K231642

Veuron-Brain-pAb3

Heuron Co., Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2023-10-13

Neuro MRI

FDA-cleared K232760

Swoop® Portable MR Imaging System®

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-10-06

MRI workflow

FDA-cleared K231398

VUNO Med-DeepBrain

VUNO Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2023-10-04

Neuro MRI

FDA-cleared K223659

Jazz

AI Medical AG

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-09-22

MRI workflow

FDA-cleared K220034

NEUROShield

In-Med Prognostics L3C

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2023-09-14

Neuro MRI

FDA-cleared K232482

MAGNETOM Viato.Mobile

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-09-06

MRI workflow

FDA-cleared K230355

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-08-30

MRI workflow

FDA-cleared K223180

AIRAscore

AIRAmed GmbH

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-08-25

MRI workflow

FDA-cleared K230913

ANDI

Imeka Solutions, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2023-07-25

MRI workflow

FDA-cleared K230150

OptimMRI

RebrAIn, SAS

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2023-07-21

MRI workflow

FDA-cleared K223426

ECHELON Synergy MRI system

FUJIFILM Healthcare Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-07-13

MRI workflow

FDA-cleared K231459

HepaFatSmart (V2.0.0)

Resonance Health Analysis Services Pty Ltd

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-06-20

MRI workflow

FDA-cleared K223523

Sonic DL

GE Medical Systems,LLC (GE Healthcare)

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-05-30

MRI workflow

FDA-cleared K223623

SubtleMR (2.3.x)

Subtle Medical Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-05-11

MRI workflow

FDA-cleared K220437

Neurophet AQUA

NEUROPHET, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2023-05-10

Neuro MRI

FDA-cleared K230552

MR DWI/FLAIR Measurement V1.0

Olea Medical

MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements;...

Modality: MRI
Anatomy: Brain
Decision: 2023-04-26

Quantification and segmentation Neuro MRI

FDA-cleared K230772

Quantib Prostate

Quantib BV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Prostate
Decision: 2023-04-17

Prostate imaging

FDA-cleared K230264

Ezra Flash

Ezra AI, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-04-13

MRI workflow

FDA-cleared K223458

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

Philips Medical Systems Nederland B.V.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-04-06

MRI workflow

FDA-cleared K223343

MAGNETOM Amira; MAGNETOM Sempra

Siemens Medical Solutions USA Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-03-28

MRI workflow

FDA-cleared K230197

BoneMRI v1.6

MRIguidance B.V.

BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.

Modality: MRI
Anatomy: Bone
Decision: 2023-02-22

MSK and bone

FDA-cleared K230208

Swoop® Portable MR Imaging System™

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-02-22

MRI workflow

FDA-cleared K222755

uMR 680

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-02-16

MRI workflow

FDA-cleared K223439

SIGNA Victor

GE Healthcare (Tianjin) Company Limited

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-02-13

MRI workflow

FDA-cleared K223502

MR Diffusion Perfusion Mismatch V1.0

Olea Medical

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2023-01-13

MRI workflow

FDA-cleared K223442

MR 5300 and MR 7700 R11 MR Systems

Philips Medical Systems Nederlands B.V.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-12-23

MRI workflow

FDA-cleared K223268

BrainInsight

Hyperfine, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2022-12-16

Neuro MRI

FDA-cleared K223247

Swoop Portable MR Imaging System

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-12-06

MRI workflow

FDA-cleared K221624

Avenda Health AI Prostate Cancer Planning Software

Avenda Health, Inc.

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality: MRI
Anatomy: Prostate
Decision: 2022-11-22

Prostate imaging

FDA-cleared K221762

BoneMRI v1.4

MRlguidance B.V.

BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.

Modality: MRI
Anatomy: Bone
Decision: 2022-11-16

MSK and bone

FDA-cleared K220332

uMR Omega with uWS-MR-MRS

Shanghai United Imaging Healthcare Co.,Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-10-27

MRI workflow

FDA-cleared K211611

QIR Suite

CASIS Cardiac Simulation & Imaging Software

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2022-09-30

MRI workflow

FDA-cleared K221738

NS-HGlio

Neosoma Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2022-09-27

MRI workflow

FDA-cleared K221733

MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-09-13

MRI workflow

FDA-cleared K213960

LiverMultiScan v5 (LMSv5)

Perspectum

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Liver
Decision: 2022-09-06

Oncology quantification

FDA-cleared K213645

ClearPoint Maestro Brain Model

ClearPoint Neuro, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2022-08-08

Neuro MRI

FDA-cleared K221923

Swoop Portable MR Imaging System

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-07-28

MRI workflow

FDA-cleared K220624

AI4CMR v1.0

AI4MedImaging Medical Solutions S.A.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-07-22

MRI workflow

FDA-cleared K220815

BrainInsight

Hyperfine, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2022-07-19

Neuro MRI

FDA-cleared K212783

ProstatID

ScanMed, LLC

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: N/A
Decision: 2022-07-08

Breast imaging Detection and CADe

FDA-cleared K220575

MAGNETOM Free.Max, MAGNETOM Free.Star

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-06-24

MRI workflow

FDA-cleared K220497

CoLumbo

Smart Soft Healthcare AD

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2022-06-23

MRI workflow

FDA-cleared K221393

Swoop Portable MR Imaging System

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-06-10

MRI workflow

FDA-cleared K213717

AIR Recon DL

GE Medical Systems,LLC (GE Healthcare)

AIR Recon DL is optional integrated GE MRI reconstruction that removes noise and ringing from supported 1.5T, 3T, and 7T acquisitions across all ages and anatomies.

Modality: MRI
Anatomy: Multi-region
Decision: 2022-06-08

MRI workflow

FDA-cleared K220416

SwiftMR

AIRS Medical Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-05-25

MRI workflow

FDA-cleared K213583

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

Philips Medical Systems Nederland B.V.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-05-16

MRI workflow

FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...

Modality: MRI
Anatomy: Multi-region
Decision: 2022-05-13

Breast imaging Detection and CADe

FDA-cleared K221106

Quantib Prostate

Quantib BV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Prostate
Decision: 2022-05-13

Prostate imaging

FDA-cleared K212519

Overjet Caries Assist

Overjet, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality: MRI
Anatomy: Dental/Maxillofacial
Decision: 2022-05-10

MRI workflow

FDA-cleared K220939

MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A

Siemens Medical Solutions USA Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-04-29

MRI workflow

FDA-cleared K213706

AI-Rad Companion Brain MR

Siemens Healthcare GmBh

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2022-04-15

Neuro MRI

FDA-cleared K220192

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-04-08

MRI workflow

FDA-cleared K220151

MAGNETOM Avanto Fit

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-04-01

MRI workflow

FDA-cleared K203744

Arterys MICA

Arterys Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Vascular
Decision: 2022-03-14

MRI workflow

FDA-cleared K213693

MAGNETOM Vida with syngo MR XA50A

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-02-25

MRI workflow

FDA-cleared K213603

SIGNA Artist Evo

GE Healthcare(Tianjin) Company Limited

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-02-11

MRI workflow

FDA-cleared K213668

SIGNA Hero

GE Healthcare (GE Medical Systems, LLC)

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-01-20

MRI workflow

FDA-cleared K211980

SIGNA Prime

GE Healthcare (Tianjin) Company Limited

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-01-16

MRI workflow

FDA-cleared K213737

Quantib ND

Quantib B.V.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2022-01-14

MRI workflow

FDA-cleared K213776

LiverSmart

Resonance Health Analysis Services Pty Ltd

FDA product code PCS identifies this device class as Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox. Intended for diagnostic use to present images that...

Modality: MRI
Anatomy: Liver
Decision: 2021-12-29

Oncology quantification

FDA-cleared K202404

BoneMRI

MRIguidance B.V

BoneMRI is image-processing software that enhances visualization of bone structures in MRI images relative to surrounding soft tissue.

Modality: MRI
Anatomy: Bone
Decision: 2021-12-22

MSK and bone

FDA-cleared K213628

VBrain

Vysioneer Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality: MRI
Anatomy: Brain
Decision: 2021-12-16

Neuro MRI

FDA-cleared K213305

Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-12-01

MRI workflow

FDA-cleared K210831

OnQ Neuro

CorTechs Labs, Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Brain
Decision: 2021-11-19

Neuro MRI

FDA-cleared K212456

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Hyperfine, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-11-17

MRI workflow

FDA-cleared K210999

SwiftMR

AIRS Medical Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-10-14

MRI workflow

FDA-cleared K211431

breastscape v1.0

Olea Medical

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Breast
Decision: 2021-08-02

Breast imaging

FDA-cleared K210611

MAGNETOM Free.Max

Siemens Medical Solutions USA, Inc.

MAGNETOM Free.Max with syngo MR XA40A is a 0.55T, 80-cm-bore system for broad head, body, and extremity diagnostic MRI.

Modality: MRI
Anatomy: Multi-region
Decision: 2021-07-01

MRI workflow

FDA-cleared K211118

SIGNA 7.0T

GE Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-05-13

MRI workflow

FDA-cleared K203443

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-03-31

MRI workflow

FDA-cleared K203323

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-03-04

MRI workflow

FDA-cleared K203182

SubtleMR

Subtle Medical, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-02-26

MRI workflow

FDA-cleared K210053

LVivo Software Application

DiA Imaging Analysis Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2021-02-05

MRI workflow

FDA-cleared K203582

QUIBIM Precision Prostate (qp-Prostate)

QUIBIM S.L.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Prostate
Decision: 2021-02-04

Prostate imaging

FDA-cleared K202767

Vantage Orian 1.5T, MRT-1550, V6.0

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2021-01-15

MRI workflow

FDA-cleared K203280

Hepatica v1 (Hepatica v1.0.0)

Perspectum Ltd.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Liver
Decision: 2021-01-12

Oncology quantification

FDA-cleared K201039

HepaFat-AI

Resonance Health Analysis Services Pty Ltd

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-12-07

MRI workflow

FDA-cleared K193287

CorInsights MRI

ADM Diagnostics, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-11-20

MRI workflow

FDA-cleared K193306

PROView

GE Medical Systems SCS

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-11-17

MRI workflow

FDA-cleared K201615

SIGNA 7.0T

GE Medical Systems, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-10-15

MRI workflow

FDA-cleared K202501

Quantib Prostate

Quantib BV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Prostate
Decision: 2020-10-11

Prostate imaging

FDA-cleared K202170

LiverMultiScan

Perspectum LTD

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Liver
Decision: 2020-10-02

Oncology quantification

FDA-cleared K192051

THINQ

CorticoMetrics LLC

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-09-30

MRI workflow

FDA-cleared K202238

SIGNA Artist

GE Healthcare (Tianjin) Company Limited

SIGNA Artist is a 1.5T whole-body MRI system; K202238 adds AIR Recon DL reconstruction to reduce noise and ringing and support improved image quality or shorter acquisitions.

Modality: MRI
Anatomy: Multi-region
Decision: 2020-09-04

MRI workflow

FDA-cleared K193283

AI-Rad Companion Prostate MR

Siemens Medical Solutions USA Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: Prostate
Decision: 2020-07-30

Prostate imaging

FDA-cleared K193097

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-07-14

MRI workflow

FDA-cleared K200232

LVivo Software Application

DiA Imaging Analysis Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2020-06-23

MRI workflow

FDA-cleared K193290

AI-Rad Companion Brain MR

Siemens Medical Solutions USA, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2020-06-17

Neuro MRI

FDA-cleared K192601

uWS-MR

Shanghai United Imaging Healthcare Co., Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality: MRI
Anatomy: N/A
Decision: 2020-06-01

MRI workflow

FDA-cleared K193176

uMR 780

Shanghai United Imaging Healthcare Co., Ltd

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-05-05

MRI workflow

FDA-cleared K193282

SIGNA Premier

GE Healthcare (GE Medical Systems, LLC)

SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option...

Modality: MRI
Anatomy: Multi-region
Decision: 2020-04-10

MRI workflow

FDA-cleared K192574

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2020-03-09

MRI workflow

FDA-cleared K192130

Icobrain

Icometrix NV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2019-12-13

Neuro MRI

FDA-cleared K192531

QyScore Software

Qynapse

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2019-12-13

MRI workflow

FDA-cleared K191278

RSI-MRI+

MultiModal Imaging Services Corporation (dba HealthLytix)

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2019-11-19

MRI workflow

FDA-cleared K183274

RTHawk, HeartVista Cardiac Package

HeartVista, Inc.

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Heart
Decision: 2019-10-18

Cardiac imaging

FDA-cleared K191493

Ventripoint Medical System Plus (VMS+) 3.0

Ventripoint Diagnostics, Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2019-10-16

MRI workflow

FDA-cleared K191688

SubtleMR

Subtle Medical, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2019-09-16

MRI workflow

FDA-cleared K190017

LiverMultiScan (LMSv3)

Perspectum Diagnostics Ltd

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Liver
Decision: 2019-06-27

Oncology quantification

FDA-cleared K183231

SIGNA Premier

GE Medical Systems, LLC

SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K183231 adds AIRx, a deep-learning pre-scan feature that automates and...

Modality: MRI
Anatomy: Multi-region
Decision: 2019-01-18

MRI workflow

FDA-cleared K183133

MRCP+ v1.0

Perspectum Diagnostics Ltd

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2019-01-09

MRI workflow

FDA-cleared K182564

Quantib ND

Quantib BV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2018-12-27

MRI workflow

FDA-cleared K173749

AMRA Profiler

AMRA Medical AB

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2018-12-06

MRI workflow

FDA-cleared K182218

FerriSmart Analysis System

Resonance Health Analysis Services Pty Ltd

FerriSmart analyzes magnetic resonance images to estimate liver iron concentration for clinician review.

Modality: MRI
Anatomy: Liver
Decision: 2018-11-30

Oncology quantification

FDA-cleared K173939

Quantib Brain

Quantib BV

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2018-03-09

Neuro MRI

FDA-cleared K173605

iQMR

Medic Vision - Imaging Solutions Ltd

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: N/A
Decision: 2018-03-08

MRI workflow

FDA-cleared K180091

UNiD Spine Analyzer

Medicrea International

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Spine
Decision: 2018-02-08

MSK and bone

FDA-cleared K171328

cNeuro cMRI

Combinostics Oy

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2018-01-08

Neuro MRI

FDA-cleared K170981

NeuroQuant

CorTechs Labs, Inc

is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...

Modality: MRI
Anatomy: Brain
Decision: 2017-09-07

Quantification and segmentation Neuro MRI

FDA-cleared K170172

UNiD Spine Analyzer

MEDICREA INTERNATIONAL

UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries.

Modality: MRI
Anatomy: Spine
Decision: 2017-05-24

MSK and bone

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

MRI workflow

FDA-cleared K163013

Quantib Brain 1.2

Quantib BV

Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).

Modality: MRI
Anatomy: Brain
Decision: 2017-01-06

Quantification and segmentation Neuro MRI

FDA-cleared K163253

Arterys Cardio DL

ARTERYS INC.

The device is intended to visualize and quantify MRI data in DICOM format.

Modality: MRI
Anatomy: Vascular
Decision: 2017-01-05

Quantification and segmentation

FDA-cleared K161148

icobrain

Icometrix

icobrain segments and quantifies brain structures and lesions from T1-weighted and FLAIR MRI using cross-sectional and longitudinal workflows with acquisition-consistency limits.

Modality: MRI
Anatomy: Brain
Decision: 2016-08-09

Quantification and segmentation Neuro MRI

FDA-cleared K153351

Quantib Brain 1

QUANTIB BV

Quantib Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS

Modality: MRI
Anatomy: Brain
Decision: 2016-06-17

Quantification and segmentation Neuro MRI

FDA-cleared K080762

IB NEURO, VERSION 1.0

IMAGING BIOMETRICS, LLC

FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.

Modality: MRI
Anatomy: Brain
Decision: 2008-05-15

Neuro MRI