Imaging Engineering, LLC 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
Insight Enhanced DRF (EN-1002-01)510(k)Sep 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 16, 2025
Insight Agile DRF510(k)Jul 27, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 27, 2021