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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 the device name listed in this FDA 510(k) record. The listed applicant is Ai4medimaging Medical Solutions S.A.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) 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. The listed applicant is Ai4medimaging Medical Solutions S.A.. The 510(k) number is K220624.

When did AI4CMR v1.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for AI4CMR v1.0?

The FDA 510(k) record lists Ai4medimaging Medical Solutions S.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ai4medimaging Medical Solutions S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252084AI4CMR v2.0

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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