Seoul, KR · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 3 | 2026-07-24 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 3 | 2023-10-27 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-24 | K261349 | SwiftMR | QIH | Class II | Radiology |
| 2026-03-26 | K253775 | SwiftMR | QIH | Class II | Radiology |
| 2025-09-23 | K251483 | SwiftSight-Brain | QIH | Class II | Radiology |
| 2023-10-27 | K230854 | SwiftMR | LLZ | Class II | Radiology |
| 2022-05-25 | K220416 | SwiftMR | LLZ | Class II | Radiology |
| 2021-10-14 | K210999 | SwiftMR | LLZ | Class II | Radiology |