510(k) · Radiology

GBrain MRI

by Galileo CDS, Inc

GBrain MRI is an AI-enabled medical device from Galileo CDS, Inc that the U.S. FDA cleared through 510(k) K250416 on April 11, 2025. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK250416
Pathway510(k)
Date of final decision
Company (FDA list)Galileo CDS, Inc
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Galileo Cds, Inc.
Applicant locationAustin, TX, US
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. GBrain MRI went through this pathway (K250416).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #190 of 305 under that code. Galileo CDS, Inc has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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