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FDA 510(k)

AI4CMR v2.0

K-Number: K252084 · 2026-02-11

ApplicantAi4medimaging Medical Solutions S.A.
Decision Date2026-02-11
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI4CMR v2.0 is a medical device manufactured by Ai4medimaging Medical Solutions S.A.. It received FDA 510(k) clearance on 2026-02-11 under approval number K252084. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI4CMR v2.0?

AI4CMR v2.0 is a medical device that received FDA 510(k) clearance on 2026-02-11. It is manufactured by Ai4medimaging Medical Solutions S.A.. The 510(k) number is K252084.

When was AI4CMR v2.0 approved by the FDA?

AI4CMR v2.0 received FDA 510(k) clearance on 2026-02-11, under approval number K252084.

What company makes AI4CMR v2.0?

AI4CMR v2.0 is manufactured by Ai4medimaging Medical Solutions S.A..

What is the FDA product code for AI4CMR v2.0?

The FDA product code for AI4CMR v2.0 is QIH.

Other Devices by Ai4medimaging Medical Solutions S.A.

K220624AI4CMR v1.0

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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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