GBrain MRI— 510(k) K250416

Substantially Equivalent

Galileo Cds, Inc.

FDA 510(k) clearance K250416 for GBrain MRI, Substantially Equivalent on 2025-04-11. 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: 2025-02-13
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Galileo Cds, Inc.

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