Hwaseong-Si, KR · 11 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 8 | 2026-07-31 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Class II | Radiology | 2 | 2025-03-12 |
| NJM | — | — | — | 1 | 2022-05-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-31 | K253800 | 0909FCE, 0909FCE-HS | MQB | Class II | Radiology |
| 2025-03-12 | K243849 | 2430TCA with Xmaru W | MUE | Class II | Radiology |
| 2024-09-09 | K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | MQB | Class II | Radiology |
| 2024-03-07 | K240371 | 0909FCC, 0909FCC-HS | MQB | Class II | Radiology |
| 2023-06-21 | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | MQB | Class II | Radiology |
| 2022-05-06 | K220689 | Vatech Clismile | NJM | — | — |
| 2021-10-18 | K212753 | 0909FCB, 1212FCA | MQB | Class II | Radiology |
| 2021-06-21 | K202902 | 2430MCA with Xmaru W | MUE | Class II | Radiology |
| 2021-04-28 | K210985 | 1717FCC | MQB | Class II | Radiology |
| 2020-10-26 | K202722 | 1212FCA | MQB | Class II | Radiology |
| 2020-07-23 | K201796 | 1717SCV, 1717SGV | MQB | Class II | Radiology |