FDA-cleared K261405

ANDI 2.2

Imeka Solutions, Inc.

ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...

Modality
MRI
Anatomy
Brain
Decision
2026-05-28
FDA-cleared K260032

Morph

BeauBrain Healthcare, Inc.

Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...

Modality
MRI
Anatomy
Brain
Decision
2026-05-13
FDA-cleared K253057

AI-Rad Companion Brain MR

Siemens Healthcare GmbH

Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.

Modality
MRI
Anatomy
Brain
Decision
2026-01-22
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 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 K251009

Cirrus Resting State fMRI Software

Sora Neuroscience, Inc.

Cirrus processes MR data, including resting-state BOLD fMRI, to provide task-analogous motor, language, and vision correlation maps in DICOM for external visualization or...

Modality
MRI
Anatomy
Brain
Decision
2025-06-06
FDA-cleared K250236

Swoop® Portable MR Imaging® System (V2)

Hyperfine, Inc.

Swoop Portable MR Imaging System V2 is a portable ultra-low-field MR system for head imaging in adult and pediatric patients, including neonates, at the point of care when a...

Modality
MRI
Anatomy
Brain
Decision
2025-05-30
FDA-cleared K251276

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

Swoop Portable MR Imaging System is a portable ultra-low-field MR system for head imaging in adult and pediatric patients at the point of care when conventional full diagnostic...

Modality
MRI
Anatomy
Brain
Decision
2025-05-21
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 K241982

DeepFoqus (DeepFoqus-Accelerate)

Foqus Technologies Inc.

DeepFoqus-Accelerate accepts and transfers brain MRI DICOM studies and reconstructs non-contrast sagittal, axial, and coronal T1, T2, and FLAIR images from supported 1.5T and 3T...

Modality
MRI
Anatomy
Brain
Decision
2025-04-04
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 K240944

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

Swoop Portable MR Imaging System is a portable ultra-low-field MR system for point-of-care head imaging in adult and pediatric patients when a conventional full diagnostic MRI...

Modality
MRI
Anatomy
Brain
Decision
2024-07-16
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

NEUROShield labels, visualizes, and quantifies hippocampal volume from brain MRI as decision support for neurologists and neuroradiologists.

Modality
MRI
Anatomy
Brain
Decision
2023-09-14
FDA-cleared K223180

AIRAscore

AIRAmed GmbH

AIRAscore automatically labels, visualizes and quantifies segmentable brain structures from MR images, replacing manual volume measurement and providing reference-adjusted reports...

Modality
MRI
Anatomy
Brain
Decision
2023-08-25
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

AI-Rad Companion Brain MR VA40 post-processes head MR images to segment and quantify brain structures and white-matter hyperintensities, compare normalized values with healthy...

Modality
MRI
Anatomy
Brain
Decision
2022-04-15
FDA-cleared K213628

VBrain

Vysioneer Inc.

VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas...

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.

AI-Rad Companion Brain MR post-processes typical head-MR T1 MPRAGE images to automatically segment and quantify brain structures, compare normalized volumes with healthy reference...

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 K182564

Quantib ND

Quantib BV

Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional...

Modality
MRI
Anatomy
Brain
Decision
2018-12-27
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 K162830

SIS Software

Surgical Information Sciences, Inc.

SIS Software fuses brain MRI with postoperative CT to visualize and localize the subthalamic nucleus for stereotactic neurosurgical planning.

Modality
MRI
Anatomy
Brain
Decision
2017-02-14
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

Post-processing of dynamic brain MRI to generate perfusion maps for trained-physician interpretation.

Modality
MRI
Anatomy
Brain
Decision
2008-05-15