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FDA 510(k)

AI-Rad Companion Organs RT

K-Number: K221305 · 2022-10-14

Decision Date2022-10-14
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Organs RT is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2022-10-14 under approval number K221305. 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 2022-10-14. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K221305.

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

AI-Rad Companion Organs RT received FDA 510(k) clearance on 2022-10-14, under approval number K221305.

What company makes AI-Rad Companion Organs RT?

AI-Rad Companion Organs RT is manufactured by Siemens Medical Solutions USA, Inc..

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.