Genoray Co., Ltd. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by Genoray Co., Ltd. Radiology ✕
23 devices
Cleared
Oct 08, 2025
GT300
Radiology
271d
Cleared
Jul 17, 2025
HESTIA
Radiology
255d
Cleared
Dec 08, 2023
DVAS (DVAS-M, DVAS-W)
Radiology
148d
Cleared
Sep 13, 2023
GenX-CR
Radiology
55d
Cleared
Jul 20, 2023
Oscar 15 & Oscar 15i
Radiology
120d
Cleared
May 19, 2022
PAPAYA 3D & PAPAYA 3D Plus
Radiology
97d
Cleared
May 19, 2022
PAPAYA & PAPAYA Plus
Radiology
94d
Cleared
Mar 09, 2022
ZEN-2090 Turbo
Radiology
273d
Cleared
Sep 16, 2020
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
Radiology
203d
Cleared
Aug 17, 2018
OSCAR (OSCAR Prime, OSCAR Classic)
Radiology
28d
Cleared
Mar 07, 2018
PORT-X IV
Radiology
170d
Cleared
Feb 09, 2018
OSCAR 15
Radiology
205d