FDA 510(k)

AI-Rad Companion Organs RT

K-Number: K252548 · 2026-04-10

Decision Date2026-04-10

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Organs RT is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2026-04-10 under approval number K252548. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion Organs RT?

AI-Rad Companion Organs RT is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K252548.

When was AI-Rad Companion Organs RT approved by the FDA?

AI-Rad Companion Organs RT received FDA 510(k) clearance on 2026-04-10, under approval number K252548.

What company makes AI-Rad Companion Organs RT?

AI-Rad Companion Organs RT is manufactured by Siemens Healthcare GmbH.

What is the FDA product code for AI-Rad Companion Organs RT?

The FDA product code for AI-Rad Companion Organs RT is QKB.

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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.