Manufacturer registered with FDA
Genoray Co., Ltd.
SEONGNAM, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 28
- 510(k) clearances
- 142007–2025
- Markets registered in
- 1376 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Genoray Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Genoray Co., Ltd. | 14 clearances | 2007–2025 | Below |
| European Union | EUDAMED | Manufacturer | GENORAY CO., Ltd. | 22 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GENORAY Co., Ltd.GENORAY CO., LTD. | 12 | 2009–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GENORAY CO., LTD.GENORAY Co., Ltd. · GENORAY CO. LTD | 11 | 2013–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GENORAY CO., LTDGENORAY Co. , Ltd. · Genoray CO.,LTD · +1 | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Genoray Co Ltd | 6 | 2021–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | GENORAY CO., LTD. | 5 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | GENORAY Co., Ltd.Genoray Co.,Ltd | 4 | 2024–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GENORAY CO., LTD. | 3 | 2022–2022 | Pure Global AI |
| China | NMPA | Registration holder | 韩国杰耐瑞株式会社GENORAY Co., Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | GENORAY Co., Ltd. | 2 | 2026–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GENORAY CO., LTD | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | GENORAY co., Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Genoray Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | GenX-CRGT300GT300-CPAPAYAPAPAYA 3D PremiumPAPAYA 3D Premium PlusPAPAYA PlusPortView | 2013 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | DVAS-MDVAS-WPORT-X IIPORT-X IVPORT-X IV VetPORT-X Ive VetVETERA DMVETERA DWVETERA PEVETERA PX 4 moreZEN-PX2ZEN-PX4ZEN-PX4 VetZEN-PX4e Vet | 2007 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | GT300GT300-CPAPAYA 3DPAPAYA 3D PlusPAPAYA 3D PremiumPAPAYA 3D Premium Plus | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Genoray Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Oct 2025 | K250060 | GT300; GT300-C | OAS Dental Computed Tomography X-Ray |
| 8 Dec 2023 | K232085 | DVAS (DVAS-M, DVAS-W) | EHD Extraoral with Timer X-Ray Unit |
| 13 Sep 2023 | K232158 | GenX-CR | MUH Digital Extraoral Source X-Ray System |
| 19 May 2022 | K220423 | PAPAYA & PAPAYA Plus | MUH Digital Extraoral Source X-Ray System |
| 19 May 2022 | K220392 | PAPAYA 3D & PAPAYA 3D Plus | OAS Dental Computed Tomography X-Ray |
| 16 Sep 2020 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | OAS Dental Computed Tomography X-Ray |
| 7 Mar 2018 | K172810 | PORT-X IV | EHD Extraoral with Timer X-Ray Unit |
| 10 Dec 2015 | K150354 | PAPAYA 3D Plus | OAS Dental Computed Tomography X-Ray |
| 31 Oct 2014 | K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 6 Nov 2013 | K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 18 Jul 2013 | K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 10 Jul 2012 | K120263 | VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 26 Apr 2010 | K092171 | VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH Digital Extraoral Source X-Ray System |
| 11 Jan 2007 | K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GENORAY CO., LTD.FDA reg. 3005843418 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9093488). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.