Genoray Co., Ltd. FDA Approvals

0 new drug approvals and 9 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
BELLIGER ACE510(k)Apr 2, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 2, 2026
GT300; GT300-C510(k)Oct 8, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 8, 2025
HESTIA510(k)Jul 17, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 17, 2025
DVAS (DVAS-M, DVAS-W)510(k)Dec 8, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
GenX-CR510(k)Sep 13, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 13, 2023
Oscar 15 & Oscar 15i510(k)Jul 20, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2023
PAPAYA & PAPAYA Plus510(k)May 19, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 19, 2022
PAPAYA 3D & PAPAYA 3D Plus510(k)May 19, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 19, 2022
ZEN-2090 Turbo510(k)Mar 9, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 9, 2022