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FDA 510(k)

GBrain MRI

K-Number: K250416 · 2025-04-11

ApplicantGalileo Cds, Inc.
Decision Date2025-04-11
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GBrain MRI is a medical device manufactured by Galileo Cds, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval number K250416. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GBrain MRI?

GBrain MRI is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Galileo Cds, Inc.. The 510(k) number is K250416.

When was GBrain MRI approved by the FDA?

GBrain MRI received FDA 510(k) clearance on 2025-04-11, under approval number K250416.

What company makes GBrain MRI?

GBrain MRI is manufactured by Galileo Cds, Inc..

What is the FDA product code for GBrain MRI?

The FDA product code for GBrain MRI is QIH.

Other Devices by Galileo Cds, Inc.

K252362GBrain MRI

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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.

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