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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
FDA-cleared K240793

MSKai

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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