Icad, 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
ProFound Detection (V4.0)510(k)Nov 8, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 8, 2024
PowerLook Density Assessment V4.0510(k)Jul 12, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 12, 2021
ProFound AI Software V3.0510(k)Mar 12, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 12, 2021