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FDA 510(k)

AI-Rad Companion Prostate MR

K-Number: K252608 · 2025-09-09

ApplicantSiemens Healthcare GmbH
Decision Date2025-09-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Prostate MR is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2025-09-09 under approval number K252608. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion Prostate MR?

AI-Rad Companion Prostate MR is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K252608.

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

AI-Rad Companion Prostate MR received FDA 510(k) clearance on 2025-09-09, under approval number K252608.

What company makes AI-Rad Companion Prostate MR?

AI-Rad Companion Prostate MR is manufactured by Siemens Healthcare GmbH.

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

The FDA product code for AI-Rad Companion Prostate MR is LLZ.

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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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