Medical Device Manufacturer · US , Flintville , TN

Genoray Co., Ltd.

23 submissions · 23 cleared · Since 2007
23
Total
23
Cleared
0
Denied

Genoray Co., Ltd. — FDA 510(k) Submissions

Genoray Co., Ltd. has submitted 23 FDA 510(k) premarket notifications since 2007, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Extraoral Source, Digital, Interventional Fluoroscopic X-ray System, X-ray, Tomography, Computed, Dental, Unit, X-ray, Extraoral With Timer, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
GT300; GT300-C
K250060 · OAS X-ray, Tomography,... · Radiology
Oct 2025 271d
HESTIA
K243420 · MUE Full Field Digital,... · Radiology
Jul 2025 255d
DVAS (DVAS-M, DVAS-W)
K232085 · EHD Unit, X-ray, Extraoral... · Radiology
Dec 2023 148d
GenX-CR
K232158 · MUH System, X-ray, Extraoral... · Radiology
Sep 2023 55d
Oscar 15 & Oscar 15i
K230787 · OWB Interventional... · Radiology
Jul 2023 120d
PAPAYA 3D & PAPAYA 3D Plus
K220392 · OAS X-ray, Tomography,... · Radiology
May 2022 97d
PAPAYA & PAPAYA Plus
K220423 · MUH System, X-ray, Extraoral... · Radiology
May 2022 94d
ZEN-2090 Turbo
K211780 · OWB Interventional... · Radiology
Mar 2022 273d
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
K200469 · OAS X-ray, Tomography,... · Radiology
Sep 2020 203d
OSCAR (OSCAR Prime, OSCAR Classic)
K181943 · OWB Interventional... · Radiology
Aug 2018 28d
PORT-X IV
K172810 · EHD Unit, X-ray, Extraoral... · Radiology
Mar 2018 170d
OSCAR 15
K172180 · OWB Interventional... · Radiology
Feb 2018 205d
PAPAYA 3D Plus
K150354 · OAS X-ray, Tomography,... · Radiology
Dec 2015 302d
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
K140041 · OWB Interventional... · Radiology
Nov 2014 324d
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K141700 · MUH System, X-ray, Extraoral... · Radiology
Oct 2014 129d
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130419 · MUH System, X-ray, Extraoral... · Radiology
Nov 2013 260d
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
K130088 · MUH System, X-ray, Extraoral... · Radiology
Jul 2013 185d
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K120263 · MUH System, X-ray, Extraoral... · Radiology
Jul 2012 162d
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103181 · LLZ System, Image Processing,... · Radiology
Aug 2011 302d
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103182 · LLZ System, Image Processing,... · Radiology
Jan 2011 78d
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K092171 · MUH System, X-ray, Extraoral... · Radiology
Apr 2010 279d
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
K091918 · OWB Interventional... · Radiology
Oct 2009 99d
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · EHD Unit, X-ray, Extraoral... · Radiology
Jan 2007 91d
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