Yongin-Si, KR · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | Class II | Radiology | 6 | 2026-04-09 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2025-05-21 |
| PNN | Orthodontic Software | Class II | Dental | 1 | 2024-05-16 |
| MUH | System, X-Ray, Extraoral Source, Digital | Class II | Dental | 1 | 2024-04-18 |
| FXX | — | — | — | 1 | 2021-05-17 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-09 | K260462 | RCT800 | OAS | Class II | Radiology |
| 2025-11-25 | K251798 | RCT700 | OAS | Class II | Radiology |
| 2025-05-21 | K251109 | SMARTDent | LLZ | Class II | Radiology |
| 2025-03-12 | K243903 | RCT600 | OAS | Class II | Radiology |
| 2024-05-16 | K233625 | RAYDENT SW | PNN | Class II | Dental |
| 2024-04-18 | K232325 | RAYSCAN a-Expert | MUH | Class II | Dental |
| 2023-08-31 | K232287 | RAYSCAN a-Expert3D | OAS | Class II | Radiology |
| 2023-04-11 | K230753 | RCT800 | OAS | Class II | Radiology |
| 2021-11-29 | K213226 | RCT700 | OAS | Class II | Radiology |
| 2021-05-17 | K211105 | Ear-Friendly Mask | FXX | — | — |