Ge Healthcare Japan Corporation FDA Approvals

0 new drug approvals and 6 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
True Definition DL510(k)Mar 23, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 23, 2026
True Enhance DL510(k)Apr 11, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 11, 2024
Deep Learning Image Reconstruction510(k)Apr 20, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 20, 2023
Deep Learning Image Reconstruction510(k)Jul 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 29, 2022
Revolution Ascend510(k)Feb 4, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 4, 2022
Deep Learning Image Reconstruction510(k)Sep 17, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 17, 2021