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GBrain MRI

by Galileo Cds, Inc. 510(k)

Active United States

510(k) K252362

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK252362 Date22 Aug 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

GBrain MRI is an AI-enabled medical device for automated segmentation, quantification, and reporting of signal hyperintensities in brain MRI. It is pathology agnostic and does not require a prior diagnosis for use.

GBrain MRI received FDA 510(k) clearance (K252362) on 2025-08-22, with a special clearance type and review by the Radiology advisory committee. It is manufactured by Galileo Cds, Inc. in Austin, Texas, and is intended for use in radiology settings to process MRI images.

Other devices from Galileo Cds, Inc.

  • GBrain MRI

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is GBrain MRI used for?

    GBrain MRI is used for automated segmentation, quantification, and reporting of signal hyperintensities in brain MRI images. It is pathology agnostic, meaning it does not require a prior diagnosis to operate, allowing radiologists to process scans for analysis regardless of suspected condition.

  • How is GBrain MRI supplied or accessed?

    GBrain MRI is a software-based medical device intended for use in radiology settings to process MRI images. It is manufactured by Galileo Cds, Inc. in Austin, Texas, and is accessed as a digital tool integrated into radiology workflows, not as a physical product shipped in units.

  • Does GBrain MRI require a prior diagnosis to function?

    No, GBrain MRI does not require a prior diagnosis for use. The device is explicitly described as pathology agnostic, meaning it can analyze brain MRI scans for signal hyperintensities without needing a pre-existing clinical diagnosis, enabling broad application in radiological assessment.