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FDA 510(k)

AI-Rad Companion Brain MR

K-Number: K232305 · 2023-10-23

ApplicantSiemens Medical Solutions U.S.A.
Decision Date2023-10-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Brain MR is a medical device manufactured by Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2023-10-23 under approval number K232305. 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 AI-Rad Companion Brain MR?

AI-Rad Companion Brain MR is a medical device that received FDA 510(k) clearance on 2023-10-23. It is manufactured by Siemens Medical Solutions U.S.A.. The 510(k) number is K232305.

When was AI-Rad Companion Brain MR approved by the FDA?

AI-Rad Companion Brain MR received FDA 510(k) clearance on 2023-10-23, under approval number K232305.

What company makes AI-Rad Companion Brain MR?

AI-Rad Companion Brain MR is manufactured by Siemens Medical Solutions U.S.A..

What is the FDA product code for AI-Rad Companion Brain MR?

The FDA product code for AI-Rad Companion Brain MR is QIH.

Other Devices by Siemens Medical Solutions U.S.A.

K222360AI-Rad Companion (Cardiovascular) K232899AI-Rad Companion Organs RT

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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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