FDA 510(k) Applications Submitted by GENORAY CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K063121 10/12/2006 PORTABLE X-RAY SYSTEM, MODEL PORT-X II GENORAY CO., LTD.
K232158 07/20/2023 GenX-CR Genoray Co., Ltd.
K130088 01/14/2013 PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM GENORAY CO., LTD.
K120263 01/30/2012 VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD.
K130419 02/19/2013 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD.
K092171 07/21/2009 VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD.
K103181 10/28/2010 ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM GENORAY CO., LTD.
K103182 10/28/2010 TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM GENORAY CO., LTD.
K181943 07/20/2018 OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd.
K172810 09/18/2017 PORT-X IV GENORAY Co., Ltd.
K220392 02/11/2022 PAPAYA 3D & PAPAYA 3D Plus GENORAY Co., Ltd.
K220423 02/14/2022 PAPAYA & PAPAYA Plus GENORAY Co., Ltd.
K230787 03/22/2023 Oscar 15 & Oscar 15i Genoray Co., Ltd.
K140041 01/08/2014 ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM GENORAY CO., LTD.
K141700 06/24/2014 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD.
K150354 02/11/2015 PAPAYA 3D Plus GENORAY CO., LTD.
K091918 06/30/2009 ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO GENORAY CO., LTD.
K211780 06/09/2021 ZEN-2090 Turbo Genoray Co., Ltd.


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