Anyang-Si, KR · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 5 | 2026-06-18 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Class II | Radiology | 2 | 2026-05-28 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2025-11-04 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-18 | K260820 | VIVIX-S 4386W (FXRD-4386WA) | MQB | Class II | Radiology |
| 2026-05-28 | K254092 | Bellalun 2D (VDMS-1000S) | MUE | Class II | Radiology |
| 2025-11-04 | K251410 | VXvue | LLZ | Class II | Radiology |
| 2025-01-16 | K241113 | VIVIX-M | MUE | Class II | Radiology |
| 2024-11-15 | K241125 | VIVIX-S 1751S | MQB | Class II | Radiology |
| 2022-09-13 | K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | MQB | Class II | Radiology |
| 2022-07-20 | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | MQB | Class II | Radiology |
| 2020-03-18 | K200418 | VIVIX-S VW | MQB | Class II | Radiology |