Data / Medical devices / South Korea / Genoray Co., Ltd.
Genoray Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 16 510(k) clearances
Genoray Co., Ltd. is registered with the FDA (registration 3005843418) in Seongnam-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005843418
- Address
- 60, Dunchon-daero 541beon-gil, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13212
- Owner or operator
- GENORAY CO., LTD. (9093488)
- Roles
- Manufacturer
- First device listed
- April 3, 2007
- Registered through
- 2026
- Brand names listed
- AREX, BELLIGER ACE, DVAS-M, DVAS-W, GT300, GT300-C, GenX-CR, HESTIA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | K252229 | BELLIGER ACE | OWB | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| October 8, 2025 | K250060 | GT300; GT300-C | OAS | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| July 17, 2025 | K243420 | HESTIA | MUE | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| December 8, 2023 | K232085 | DVAS (DVAS-M, DVAS-W) | EHD | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| September 13, 2023 | K232158 | GenX-CR | MUH | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| July 20, 2023 | K230787 | Oscar 15 & Oscar 15i | OWB | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| May 19, 2022 | K220423 | PAPAYA & PAPAYA Plus | MUH | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| May 19, 2022 | K220392 | PAPAYA 3D & PAPAYA 3D Plus | OAS | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| March 9, 2022 | K211780 | ZEN-2090 Turbo | OWB | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| September 16, 2020 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | OAS | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| August 17, 2018 | K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | OWB | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| March 7, 2018 | K172810 | PORT-X IV | EHD | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| February 9, 2018 | K172180 | OSCAR 15 | OWB | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| November 28, 2014 | K140041 | ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM | OWB | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| July 18, 2013 | K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM | MUH | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
| January 11, 2007 | K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | EHD | Substantially Equivalent | Genoray Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Full Field Digital, System, X-Ray, Mammographic
Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.