GBrain MRI
K-Number: K250416 · 2025-04-11
Device Summary
Frequently Asked Questions
What is the GBrain MRI?
GBrain MRI is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Galileo Cds, Inc.. The 510(k) number is K250416.
When did GBrain MRI receive FDA 510(k) clearance?
GBrain MRI received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250416.
Who is the listed applicant for GBrain MRI?
The FDA 510(k) record lists Galileo Cds, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GBrain MRI?
The FDA product code for GBrain MRI is QIH.
Other records listing Galileo Cds, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QIH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.