| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | Class II | Radiology | 4 | 2026-03-24 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 3 | 2025-02-25 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2024-06-21 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-24 | K252421 | JLK-NCCT | QAS | Class II | Radiology |
| 2025-03-03 | K243611 | JLK-SDH | QAS | Class II | Radiology |
| 2025-02-25 | K250348 | JLK-AILink | LLZ | Class II | Radiology |
| 2025-01-03 | K243363 | JLK-ICH | QAS | Class II | Radiology |
| 2024-11-04 | K242709 | JLK-PWI | LLZ | Class II | Radiology |
| 2024-10-16 | K242556 | JLK-CTP | LLZ | Class II | Radiology |
| 2024-09-27 | K241480 | JBS-LVO | QAS | Class II | Radiology |
| 2024-06-21 | K233196 | Medihub Prostate | QIH | Class II | Radiology |