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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