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
Cleared
Dec 10, 2015
PAPAYA 3D Plus
Radiology
302d
Cleared
Nov 28, 2014
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
Radiology
324d
Cleared
Oct 31, 2014
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Radiology
129d
Cleared
Nov 06, 2013
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Radiology
260d
Cleared
Jul 18, 2013
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
Radiology
185d
Cleared
Jul 10, 2012
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Radiology
162d
Cleared
Aug 26, 2011
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Radiology
302d
Cleared
Jan 14, 2011
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Radiology
78d
Cleared
Apr 26, 2010
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Radiology
279d
Cleared
Oct 07, 2009
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
Radiology
99d
Cleared
Jan 11, 2007
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
Radiology
91d