Minnetonka, MN, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 3 | 2025-11-28 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2026-05-22 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2022-10-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-22 | K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | QIH | Class II | Radiology |
| 2025-11-28 | K252217 | CT VScore+ | JAK | Class II | Radiology |
| 2025-04-10 | K243240 | Vitrea CT VScore | JAK | Class II | Radiology |
| 2023-07-13 | K223261 | Open Rib | JAK | Class II | Radiology |
| 2022-10-14 | K222662 | Vitrea CT Cardiac Analysis | LLZ | Class II | Radiology |