Imeka Solutions, Inc. FDA Approvals

0 new drug approvals and 3 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
ANDI 2.2510(k)May 28, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 28, 2026
ANDI 2.0510(k)Oct 22, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2025
ANDI510(k)Jul 25, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 25, 2023