Genoray Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250060GT300; GT300-COctober 8, 2025
K243420HESTIAJuly 17, 2025
K232085DVAS (DVAS-M, DVAS-W)December 8, 2023
K232158GenX-CRSeptember 13, 2023
K230787Oscar 15 & Oscar 15iJuly 20, 2023
K220423PAPAYA & PAPAYA PlusMay 19, 2022
K220392PAPAYA 3D & PAPAYA 3D PlusMay 19, 2022
K211780ZEN-2090 TurboMarch 9, 2022
K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusSeptember 16, 2020
K181943OSCAR (OSCAR Prime, OSCAR Classic)August 17, 2018
K172810PORT-X IVMarch 7, 2018
K172180OSCAR 15February 9, 2018
K150354PAPAYA 3D PlusDecember 10, 2015
K140041ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEMNovember 28, 2014
K141700PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMOctober 31, 2014
K130419PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMNovember 6, 2013
K130088PORT VIEW, DIGITAL X-RAY SENSOR SYSTEMJuly 18, 2013
K120263VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMJuly 10, 2012
K103181ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMAugust 26, 2011
K103182TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMJanuary 14, 2011