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 K252298

ANDI 2.0

Imeka Solutions, Inc.

Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical...

Modality
MRI
Anatomy
Brain
Decision
2025-10-22
FDA-cleared K251483

SwiftSight-Brain

AIRS Medical Inc.

Adjunctive brain MRI morphometry and lesion-quantification support for qualified healthcare professionals, including segmented overlays, volumetric measurements, normative...

Modality
MRI
Anatomy
Brain
Decision
2025-09-23
FDA-cleared K243681

Neuro Insight V1.0

Olea Medical S.A.S.

Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter...

Modality
MRI
Anatomy
Brain
Decision
2025-07-23
FDA-cleared K250686

GyriCalc (Version 1.0.0)

NeuroSpectrum Insights Corp.

Adjunctive quantitative brain-mapping report for qualified clinical interpretation of children 24-36 months, providing regional volume, surface-area and local-gyrification...

Modality
MRI
Anatomy
Brain
Decision
2025-07-22
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 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.

Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data...

Modality
MRI
Anatomy
Brain
Decision
2024-10-25
FDA-cleared K241098

NeuroQuant

CorTechs Labs, Inc.

NeuroQuant automatically labels, visualizes, and volumetrically quantifies segmentable brain structures and lesions from MR images, optionally using T2 FLAIR and T2* GRE/SWI for...

Modality
MRI
Anatomy
Brain
Decision
2024-08-22
FDA-cleared K240290

AiMIFY (1.x)

Subtle Medical, Inc.

Enhance GBCA-enhanced brain MRI images to improve lesion and tissue contrast for radiologist review while preserving the original post-contrast image context.

Modality
MRI
Anatomy
Brain
Decision
2024-08-21
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 K231929

iQ-solutions

Sydney Neuroimaging Analysis Centre Pty Ltd

Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same...

Modality
MRI
Anatomy
Brain
Decision
2023-12-18
FDA-cleared K232231

QP-Brain®

Quibim S.L.

Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and...

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.

Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a...

Modality
MRI
Anatomy
Brain
Decision
2023-10-13
FDA-cleared K223659

Jazz

AI Medical AG

Jazz semi-automatically labels, visualizes, and quantifies segmentable brain structures on MR for patients with known multiple sclerosis and/or brain metastasis, with...

Modality
MRI
Anatomy
Brain
Decision
2023-09-22
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 K230913

ANDI

Imeka Solutions, Inc.

ANDI processes diffusion-weighted MRI with auxiliary T1 imaging to create 3D white-matter tract maps and microstructure reports for trained medical professionals as adjunctive...

Modality
MRI
Anatomy
Brain
Decision
2023-07-25
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

icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended...

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

NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images.

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