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FDA 510(k)

AI4CMR v1.0

K-Number: K220624 · 2022-07-22

ApplicantAi4medimaging Medical Solutions S.A.
Decision Date2022-07-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI4CMR v1.0 is a medical device manufactured by Ai4medimaging Medical Solutions S.A.. It received FDA 510(k) clearance on 2022-07-22 under approval number K220624. 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 AI4CMR v1.0?

AI4CMR v1.0 is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Ai4medimaging Medical Solutions S.A.. The 510(k) number is K220624.

When was AI4CMR v1.0 approved by the FDA?

AI4CMR v1.0 received FDA 510(k) clearance on 2022-07-22, under approval number K220624.

What company makes AI4CMR v1.0?

AI4CMR v1.0 is manufactured by Ai4medimaging Medical Solutions S.A..

What is the FDA product code for AI4CMR v1.0?

The FDA product code for AI4CMR v1.0 is LLZ.

Other Devices by Ai4medimaging Medical Solutions S.A.

K252084AI4CMR v2.0

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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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