Ge Hualun Medical Systems Co. , Ltd. FDA Approvals

0 new drug approvals and 5 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
OEC One CFD510(k)Nov 26, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 26, 2025
Definium Tempo Select510(k)Aug 28, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2025
OEC One ASD510(k)Dec 27, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 27, 2024
Definium Pace Select ET510(k)Oct 1, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 1, 2024
Definium Pace Select510(k)Sep 12, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 12, 2023