FDA 510(k)

Prostate MR AI (VA10A)

K-Number: K241770 · 2025-03-05

Decision Date2025-03-05

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Prostate MR AI (VA10A) is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2025-03-05 under approval number K241770. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prostate MR AI (VA10A)?

Prostate MR AI (VA10A) is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K241770.

When was Prostate MR AI (VA10A) approved by the FDA?

Prostate MR AI (VA10A) received FDA 510(k) clearance on 2025-03-05, under approval number K241770.

What company makes Prostate MR AI (VA10A)?

Prostate MR AI (VA10A) is manufactured by Siemens Healthcare GmbH.

What is the FDA product code for Prostate MR AI (VA10A)?

The FDA product code for Prostate MR AI (VA10A) is QDQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.