Omega Medical Imaging, LLC 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
Soteria E-View510(k)Jan 6, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 6, 2025
Nyquist.IQ510(k)Dec 13, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2021
Soteria.AI510(k)Nov 17, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2021