Company ยท KR
Genoray Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K252229 | BELLIGER ACE Genoray Co., Ltd., CN | OWB |
| Oct 8, 2025 | K250060 | GT300; GT300-C Genoray Co., Ltd., KR | OAS |
| Jul 17, 2025 | K243420 | HESTIA Genoray Co., Ltd., KR | MUE |
| Dec 8, 2023 | K232085 | DVAS (DVAS-M, DVAS-W) Genoray Co., Ltd., KR | EHD |
| Sep 13, 2023 | K232158 | GenX-CR Genoray Co., Ltd., KR | MUH |
| Jul 20, 2023 | K230787 | Oscar 15 & Oscar 15i Genoray Co., Ltd., KR | OWB |
| May 19, 2022 | K220423 | PAPAYA & PAPAYA Plus Genoray Co., Ltd., KR | MUH |
| May 19, 2022 | K220392 | PAPAYA 3D & PAPAYA 3D Plus Genoray Co., Ltd., KR | OAS |
| Mar 9, 2022 | K211780 | ZEN-2090 Turbo Genoray Co., Ltd., KR | OWB |
| Sep 16, 2020 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus Genoray Co., Ltd., KR | OAS |
| Aug 17, 2018 | K181943 | OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd., KR | OWB |
| Mar 7, 2018 | K172810 | PORT-X IV Genoray Co., Ltd., KR | EHD |
| Feb 9, 2018 | K172180 | OSCAR 15 Genoray Co., Ltd., KR | OWB |
| Dec 10, 2015 | K150354 | PAPAYA 3D Plus Genoray Co., Ltd., KR | OAS |
| Nov 28, 2014 | K140041 | ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM Genoray Co., Ltd. | OWB |
| Oct 31, 2014 | K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Nov 6, 2013 | K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Jul 18, 2013 | K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM Genoray Co., Ltd. | MUH |
| Jul 10, 2012 | K120263 | VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Aug 26, 2011 | K103181 | ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Genoray Co., Ltd. | LLZ |
| Jan 14, 2011 | K103182 | TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Genoray Co., Ltd. | LLZ |
| Apr 26, 2010 | K092171 | VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. | MUH |
| Oct 7, 2009 | K091918 | ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO Genoray Co., Ltd. | OWB |
| Jan 11, 2007 | K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II Genoray Co., Ltd. | EHD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||