GBrain MRI

JSON twin: https://www.healthaidb.com/software/gbrain-mri.json

Company Name

Galileo CDS

Product URL

https://galileocds.com/gbrainmanual/

Company URL

https://galileocds.com

Categories

• clinical Decision Support
• imaging Software
• radiology
• ai Clinical Documentation Integrity
• medical Device Software
• Medical Imaging
• Artificial Intelligence
• Software As A Medical Device

Summary

GBrain MRI is an AI-powered software developed by Galileo CDS to assist radiologists in analyzing brain MRI scans by automatically segmenting and quantifying signal hyperintensities in FLAIR images, thereby enhancing clinical assessment efficiency.

Description

GBrain MRI is a post-processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in brain FLAIR MRI images. It provides automatic segmentation, quantification, and reporting of derived image metrics, supporting radiologists in evaluating brain MRI scans without replacing the physician's judgment. The software is not intended for specific disease diagnosis or signal hyperintensity detection. It operates virtually within the PACS environment and is intended for use in diagnostic radiology settings under the supervision of a board-certified radiologist. GBrain MRI is contraindicated for use in pediatric patient populations and in patients who have undergone brain tumor or other resection surgery. Users should confirm the presence of FLAIR hyperintensities before using the software, as it is not designed to detect them. The software is not intended for direct image-guided treatments, radiotherapy, or surgical tumor resection. Radiologists should review the GBrain MRI annotated images concurrently with original images before using the calculated volumes provided by the software. All images must have proper DICOM tags, as performance may be reduced on images without correct tags.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE certification
• ISO 27001
• SOC 2

Company Founding

2015

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• ISO 27001
• SOC 2
• FDA 510(k) clearance

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automatic segmentation of T2w FLAIR brain MRI images
• Quantification and reporting of hyperintensities' volume and maximum diameter
• Integration with PACS systems via DICOM
• Stateless operation with no long-term data storage

Id

SW0045

Integration Partners

Integrations

• PACS systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0045

Product Name

GBrain MRI

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• Audit logs
• 2FA
• DLP

Specialties

• Neurology
• Radiology

Support Channels

System Requirements

Linux-based OS supporting Docker, Nvidia GPUs with relevant drivers

Target Users

• radiologists
• clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "GBrain MRI",
  "company_name": "Galileo CDS",
  "product_url": "https://galileocds.com/gbrainmanual/",
  "company_url": "https://galileocds.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0045",
  "summary": "GBrain MRI is an AI-powered software developed by Galileo CDS to assist radiologists in analyzing brain MRI scans by automatically segmenting and quantifying signal hyperintensities in FLAIR images, thereby enhancing clinical assessment efficiency.",
  "description": "GBrain MRI is a post-processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in brain FLAIR MRI images. It provides automatic segmentation, quantification, and reporting of derived image metrics, supporting radiologists in evaluating brain MRI scans without replacing the physician's judgment. The software is not intended for specific disease diagnosis or signal hyperintensity detection. It operates virtually within the PACS environment and is intended for use in diagnostic radiology settings under the supervision of a board-certified radiologist. GBrain MRI is contraindicated for use in pediatric patient populations and in patients who have undergone brain tumor or other resection surgery. Users should confirm the presence of FLAIR hyperintensities before using the software, as it is not designed to detect them. The software is not intended for direct image-guided treatments, radiotherapy, or surgical tumor resection. Radiologists should review the GBrain MRI annotated images concurrently with original images before using the calculated volumes provided by the software. All images must have proper DICOM tags, as performance may be reduced on images without correct tags.",
  "categories": [
    "clinical Decision Support",
    "imaging Software",
    "radiology",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "medical Device Software",
    "Clinical Decision Support",
    "Medical Imaging",
    "Radiology",
    "Artificial Intelligence",
    "Software As A Medical Device"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "clinicians"
  ],
  "specialties": [
    "Neurology",
    "Radiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Linux"
  ],
  "features": [
    "Automatic segmentation of T2w FLAIR brain MRI images",
    "Quantification and reporting of hyperintensities' volume and maximum diameter",
    "Integration with PACS systems via DICOM",
    "Stateless operation with no long-term data storage"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS systems"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "Linux-based OS supporting Docker, Nvidia GPUs with relevant drivers",
  "compliance": [
    "HIPAA",
    "GDPR",
    "ISO 27001",
    "SOC 2",
    "FDA 510(k) clearance"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE certification",
    "ISO 27001",
    "SOC 2"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0045",
  "slug": "gbrain-mri",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/gbrain-mri.json"
  }
}