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Genoray Co., Ltd.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252229 BELLIGER ACEOWB2026-04-02 View
510(k) K250060 GT300; GT300-COAS2025-10-08 View
510(k) K243420 HESTIAMUE2025-07-17 View
510(k) K232085 DVAS (DVAS-M, DVAS-W)EHD2023-12-08 View
510(k) K232158 GenX-CRMUH2023-09-13 View
510(k) K230787 Oscar 15 & Oscar 15iOWB2023-07-20 View
510(k) K220423 PAPAYA & PAPAYA PlusMUH2022-05-19 View
510(k) K220392 PAPAYA 3D & PAPAYA 3D PlusOAS2022-05-19 View
510(k) K211780 ZEN-2090 TurboOWB2022-03-09 View
510(k) K200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusOAS2020-09-16 View
510(k) K181943 OSCAR (OSCAR Prime, OSCAR Classic)OWB2018-08-17 View
510(k) K172810 PORT-X IVEHD2018-03-07 View
510(k) K172180 OSCAR 15OWB2018-02-09 View
510(k) K130419 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2013-11-06 View
510(k) K130088 PORT VIEW, DIGITAL X-RAY SENSOR SYSTEMMUH2013-07-18 View
510(k) K120263 VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2012-07-10 View
510(k) K103181 ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZ2011-08-26 View
510(k) K103182 TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMLLZ2011-01-14 View
510(k) K092171 VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMMUH2010-04-26 View
510(k) K091918 ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PROOWB2009-10-07 View
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