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FDA 510(k)

AI-Rad Companion (Cardiovascular)

K-Number: K222360 · 2023-04-06

ApplicantSiemens Medical Solutions U.S.A.
Decision Date2023-04-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion (Cardiovascular) is a medical device manufactured by Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2023-04-06 under approval number K222360. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion (Cardiovascular)?

AI-Rad Companion (Cardiovascular) is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Siemens Medical Solutions U.S.A.. The 510(k) number is K222360.

When was AI-Rad Companion (Cardiovascular) approved by the FDA?

AI-Rad Companion (Cardiovascular) received FDA 510(k) clearance on 2023-04-06, under approval number K222360.

What company makes AI-Rad Companion (Cardiovascular)?

AI-Rad Companion (Cardiovascular) is manufactured by Siemens Medical Solutions U.S.A..

What is the FDA product code for AI-Rad Companion (Cardiovascular)?

The FDA product code for AI-Rad Companion (Cardiovascular) is JAK.

Other Devices by Siemens Medical Solutions U.S.A.

K232305AI-Rad Companion Brain MR K232899AI-Rad Companion Organs RT

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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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