Ge Healthcare (Tianjin) Company Limited FDA Approvals

0 new drug approvals and 4 device clearances on file. Matched by name to GEHC.

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
SIGNA Champion510(k)Jan 19, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 19, 2024
SIGNA Victor510(k)Feb 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 13, 2023
SIGNA Artist Evo510(k)Feb 11, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 11, 2022
SIGNA Prime510(k)Jan 16, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 16, 2022