Ai4medimaging Medical Solutions S.A. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
AI4CMR v2.0510(k)Feb 11, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Feb 11, 2026
AI4CMR v1.0510(k)Jul 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 22, 2022