GBrain MRI— 510(k) K252362

Substantially Equivalent

Galileo Cds, Inc.

FDA 510(k) clearance K252362 for GBrain MRI, Substantially Equivalent on 2025-08-22. Applicant: Galileo Cds, Inc.. Device class: 2.

Clearance details

Applicant: Galileo Cds, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-07-29
Decision date: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.