Imagen Technologies, Inc. FDA Approvals

0 new drug approvals and 4 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
Lung-CAD510(k)Oct 3, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 3, 2023
Lung-CAD510(k)Sep 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2023
Aorta-CAD510(k)Sep 20, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 20, 2022
Chest-CAD510(k)Jul 20, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2021