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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2023-10-23 under 510(k) 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. The listed applicant is Siemens Medical Solutions U.S.A.. The 510(k) number is K232305.

When did AI-Rad Companion Brain MR receive FDA 510(k) clearance?

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

Who is the listed applicant for AI-Rad Companion Brain MR?

The FDA 510(k) record lists Siemens Medical Solutions U.S.A. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Siemens Medical Solutions U.S.A. 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.

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Official Source

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