Seongnam-Si, KR · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OWB | — | — | — | 3 | 2026-04-02 |
| OAS | X-Ray, Tomography, Computed, Dental | Class II | Radiology | 3 | 2025-10-08 |
| MUH | System, X-Ray, Extraoral Source, Digital | Class II | Dental | 2 | 2023-09-13 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Class II | Radiology | 1 | 2025-07-17 |
| EHD | — | — | — | 1 | 2023-12-08 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-02 | K252229 | BELLIGER ACE | OWB | — | — |
| 2025-10-08 | K250060 | GT300; GT300-C | OAS | Class II | Radiology |
| 2025-07-17 | K243420 | HESTIA | MUE | Class II | Radiology |
| 2023-12-08 | K232085 | DVAS (DVAS-M, DVAS-W) | EHD | — | — |
| 2023-09-13 | K232158 | GenX-CR | MUH | Class II | Dental |
| 2023-07-20 | K230787 | Oscar 15 & Oscar 15i | OWB | — | — |
| 2022-05-19 | K220423 | PAPAYA & PAPAYA Plus | MUH | Class II | Dental |
| 2022-05-19 | K220392 | PAPAYA 3D & PAPAYA 3D Plus | OAS | Class II | Radiology |
| 2022-03-09 | K211780 | ZEN-2090 Turbo | OWB | — | — |
| 2020-09-16 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | OAS | Class II | Radiology |