GBrain MRI

by Galileo CDS, Inc.  · Based in United States → — TRANSFORMING. RADIOLOGY. Built by Radiologists for Radiologist.
Neurology Radiology
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Regulatory Status Disclosed

Overview

GBrain MRI by Galileo CDS, Inc. is an AI-powered software designed for the automated post-processing and analysis of brain MRI images. It assists radiologists in interpreting brain scans more efficiently by providing quantitative measurements of signal hyperintensities.

The software is a fully automated medical device intended for analyzing and quantitatively reporting known signal hyperintensities in brain MR images, specifically on T2w FLAIR MR images and T1w post-contrast images, within the context of diagnostic radiology.

GBrain MRI provides automatic segmentation, quantification, and reporting of derived image metrics. It is not intended for the detection or specific diagnosis of any disease, nor for the detection of signal hyperintensities, and should not be used in lieu of a full evaluation of the patient’s MRI scans.

The technology utilizes a proprietary automated pipeline that includes skull stripping, signal normalization, deep learning-based segmentation of hyperintensities, volume calculations, and report generation. It produces outputs in standard DICOM formats compatible with PACS systems and operates without user interaction after installation.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated post-processing of brain MRI images
  • Quantitative analysis of signal hyperintensities
  • Automatic segmentation of hyperintensities
  • Volume calculations of hyperintensities
  • Automated report generation
  • Deep learning-based segmentation
  • Skull stripping and signal normalization
  • Outputs in standard DICOM formats (Secondary Capture DICOM, DICOM Encapsulated PDF, DICOM SR)
  • Compatible with PACS systems
  • Intended for adult population only

Use Cases

  • Aiding radiologists in interpreting brain MR images
  • Supporting evaluation of brain MRI scans
  • Enhancing clinical assessment of brain MRIs
  • Providing quantitative measurements for hyperintensities
  • Streamlining radiology workflow for brain MRI analysis
  • Assisting in the analysis of T2w FLAIR and T1w post-contrast brain MR images

What Physicians Need to Know

Brain MRI Analysis
GBrain MRI is an AI-powered software for automated post-processing of brain MRI images, specifically analyzing and quantitatively reporting signal hyperintensities on FLAIR MR images and T1w post-contrast images.
Automated Segmentation & Quantification
The tool provides automatic segmentation, quantification, and reporting of derived image metrics, utilizing a proprietary pipeline for skull stripping, signal normalization, deep learning-based segmentation of hyperintensities, volume calculations, and report generation.
Workflow Efficiency
It helps radiologists interpret brain scans more efficiently by automating the post-processing of MRI images.
Output & Compatibility
Outputs are generated in standard DICOM formats (Secondary Capture DICOM, DICOM Encapsulated PDF, DICOM SR) and are compatible with most third-party DICOM workstations and Picture Archive and Communications Systems (PACS).
FDA Clearance
GBrain MRI is an FDA-cleared medical device.
Physician Tip

GBrain MRI serves as a support tool for trained radiologists, providing complementary quantitative information for the assessment of structural adult brain MRIs. It is crucial to remember that the software is not intended for the detection or specific diagnosis of any disease, nor for the initial detection of signal hyperintensities. Physicians retain ultimate responsibility for making final patient management and treatment decisions, which should not be based solely on the device's results.

The system operates without user interaction after installation and facilitates DICOM file transfers. Its outputs are in standard DICOM formats, ensuring broad compatibility with existing third-party DICOM workstations and PACS for seamless integration into current radiology workflows.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact-for-pricing
DeploymentCloud-based
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status 1 AI-estimated

GBrain MRI by Galileo CDS, Inc. has received 510(k) premarket notification clearance from the FDA under K252362, with an approval date of August 22, 2025. It is classified as a Class II medical device (21 CFR 892.2050) for medical image management and processing. A predicate device for GBrain MRI is K250416, which was approved on April 11, 2025.
Integrations
EHR Not specified
Specialties Neurology, Radiology

What the Web Says

GBrain MRI, developed by Galileo CDS, Inc., is a post-processing medical device software that analyzes brain MRI images to automatically segment and quantify signal hyperintensities on T2-weighted FLAIR and T1-weighted post-contrast images. It provides volumetric measurements and visual overlays to aid radiologists in quantitative assessment of structural brain MRIs in diagnostic radiology contexts. The software is intended as a support tool for radiologists and not for detection or specific diagnosis of any disease.

Overall: Positive

Strengths

  • Automated segmentation and quantification of signal hyperintensities on T2w FLAIR and T1w post-contrast images.
  • Provides volumetric measurements and visual overlays.
  • Outputs in standard DICOM format, compatible with most third-party DICOM workstations and PACS.
  • Designed to be used as a support tool for radiologists, offering complementary quantitative information.
  • Performance testing demonstrated similar accuracy and reliability to predicate devices.
  • Extends functionality by adding segmentation capability for contrast-enhancing regions on T1-weighted post-contrast images.

Limitations

  • Not intended for detection or specific diagnosis of any disease.
  • Should not be used in lieu of a full evaluation of the patient's MRI scans; physician retains ultimate responsibility.
  • Contraindicated for use in pediatric patient populations and in patients who have undergone brain tumor or other resection surgery.
  • Requires trained personnel for installation and use.
  • No user interface after installation.

Based on reviews from: Predicase, accessdata.fda.gov

Last updated: 2026-07-18

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Press & Coverage

accessdata.fda.gov
K252362 - GBrain MRI FDA 510(k) Clearance
This regulatory announcement details the FDA 510(k) clearance for GBrain MRI, a post-processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in the brain on T2w FLAIR MR images and T1w post-contrast images. It specifies the device's intended use for automatic segmentation, quantification, and reporting of derived image metrics, while clarifying it is not for disease detection or specific diagnosis.
2025-08
FDA
K250416 - 510(k) Premarket Notification - FDA
This FDA premarket notification provides details for Galileo CDS, Inc.'s GBrain MRI, identifying it as a Class II medical image management and processing system under regulation number 892.2050. It lists the applicant and correspondent contacts and the product code QIH.
2026-06
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
This article from Innolitics, a healthcare IT publication, lists Galileo CDS GBrain MRI (K2523622025) among the AI/ML devices authorized by the FDA in Q2 2026. It highlights the continued dominance of radiology in AI/ML device authorizations and discusses the significance of De Novo grants in creating new device classifications.
2026-07
Innolitics
First FDA-Cleared AI Agent and LLM Enabled Device Confirmed - Innolitics
Innolitics mentions Galileo CDS GBrain MRI (K2523622025) in an article discussing FDA-cleared AI/ML devices, providing context on the regulatory landscape for AI in healthcare. The article primarily focuses on a different device but includes GBrain MRI in a list of cleared AI products.
2026-06
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
This article references Galileo CDS's GBrain MRI (K252362) in a discussion about ground truthing methodologies for AI/ML SaMDs, specifically mentioning how its segmentation performance was evaluated against expert-labeled segmentations using a STAPLE algorithm.
2025-09
Innolitics
AI/ML from Idea to FDA - Innolitics
Galileo CDS GBrain MRI (K2523622025) is listed in this Innolitics article that outlines the process of developing and obtaining FDA clearance for AI/ML algorithms, emphasizing the different phases from exploration to documentation.
2024-03
Innolitics
What Should an FDA AI Model Description Include? - Innolitics
This Innolitics article, discussing the necessary components of an FDA AI model description, includes Galileo CDS GBrain MRI (K2523622025) in a list of AI-powered medical devices. It highlights the importance of detailing technical mechanisms, inputs, outputs, and architectural choices for regulatory submissions.
2026-07
HealthAI
Medical Imaging & Radiology u2014 Health AI Companies | HealthAI
HealthAI lists Galileo CDS as the developer of GBrain MRI, noting it as an FDA-cleared solution with multiple regulatory approvals including NMPA, CE, UKCA, and PMDA.
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Videos

Product demos, reviews, and walkthroughs for GBrain MRI.

View all on YouTube

Frequently Asked Questions

GBrain MRI AI is designed to integrate seamlessly with your current PACS and RIS systems, often providing automated pre-analysis or quantitative reports directly into the imaging viewer. This aims to streamline the interpretation process by highlighting anomalies or providing measurements, allowing radiologists to focus on critical review and diagnosis.
GBrain MRI AI holds relevant regulatory approvals, such as FDA 510(k) clearance or CE Mark, for its intended use, ensuring it meets stringent safety and performance standards. It employs robust encryption, de-identification, and access control protocols to comply with patient data privacy regulations like HIPAA and GDPR, ensuring sensitive information is protected.
Alternatives include traditional manual interpretation by neuroradiologists, which remains the gold standard, and other AI-powered solutions from different vendors focusing on specific pathologies or general brain volumetry. Physicians might also consider advanced MRI sequences or functional imaging techniques as complementary tools for comprehensive assessment.
Pricing for GBrain MRI AI typically involves subscription-based models, often tiered by scan volume or number of users, or a per-study fee. Some vendors may offer capital expenditure options for larger institutions, with customizable packages available to suit varying practice sizes and budgetary needs.
GBrain MRI AI may have limitations in detecting rare pathologies, interpreting complex artifacts, or performing optimally on atypical scan protocols not adequately represented in its training data. Physicians must be aware of potential biases stemming from the AI's training dataset, which could affect its performance across diverse patient populations or imaging equipment.
GBrain MRI AI has undergone rigorous validation through extensive retrospective and prospective studies, often comparing its performance against expert neuroradiologist interpretations. Key performance metrics such as sensitivity, specificity, positive predictive value, and negative predictive value are typically published in peer-reviewed literature and available for review.
GBrain MRI AI typically offers comprehensive training programs for radiologists, technologists, and IT staff, covering installation, workflow integration, and result interpretation. Ongoing technical support, including troubleshooting and software updates, is usually provided through dedicated support channels to ensure continuous optimal performance and user proficiency.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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