Genoray Co., Ltd.
Seongnam-si Gyeonggi, KR
GENORAY CO., LTD. appears in FDA device records in Seongnam-si Gyeonggi, KR. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Genoray Co., Ltd. between 2007 and 2026. The busiest year on record is 2018, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2018 | 3 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252229 | BELLIGER ACE | OWB | Substantially Equivalent | |
| K250060 | GT300; GT300-C | OAS | Substantially Equivalent | |
| K243420 | HESTIA | MUE | Substantially Equivalent | |
| K232085 | DVAS (DVAS-M, DVAS-W) | EHD | Substantially Equivalent | |
| K232158 | GenX-CR | MUH | Substantially Equivalent | |
| K230787 | Oscar 15 & Oscar 15i | OWB | Substantially Equivalent | |
| K220423 | PAPAYA & PAPAYA Plus | MUH | Substantially Equivalent | |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | OAS | Substantially Equivalent | |
| K211780 | ZEN-2090 Turbo | OWB | Substantially Equivalent | |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | OAS | Substantially Equivalent | |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | OWB | Substantially Equivalent | |
| K172810 | PORT-X IV | EHD | Substantially Equivalent | |
| K172180 | OSCAR 15 | OWB | Substantially Equivalent | |
| K150354 | PAPAYA 3D Plus | OAS | Substantially Equivalent | |
| K140041 | ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM | OWB | Substantially Equivalent | |
| K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | |
| K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | |
| K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM | MUH | Substantially Equivalent | |
| K120263 | VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | |
| K103181 | ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | LLZ | Substantially Equivalent | |
| K103182 | TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | LLZ | Substantially Equivalent | |
| K092171 | VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | MUH | Substantially Equivalent | |
| K091918 | ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO | OWB | Substantially Equivalent | |
| K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | EHD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005843418 | 3005843418 | GENORAY CO., LTD. | 60, Dunchon-daero 541beon-gil, Jungwon-gu, Seongnam-si Gyeonggi 13212 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MUEFull Field Digital, System, X-Ray, Mammographic
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- OWBInterventional Fluoroscopic X-Ray System
- LLZSystem, Image Processing, Radiological
- MUHSystem, X-Ray, Extraoral Source, Digital
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- EHDUnit, X-Ray, Extraoral With Timer
- OASX-Ray, Tomography, Computed, Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain