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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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