GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 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
Lunar Astra510(k)Apr 20, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 20, 2026
Automated Aortic Stenosis Software (AutoAS)510(k)Mar 27, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 27, 2026
Vivid iq510(k)Jul 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 18, 2022
ViewPoint 6510(k)Jan 15, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jan 15, 2021