Helsinki Uusimaa, FL, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 4 | 2025-09-29 |
| OSN | Software For Diagnosis/Treatment | Class II | Orthopedic | 1 | 2026-02-26 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2021-02-05 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-26 | K253764 | ENOS Software Guided External Fixation System | OSN | Class II | Orthopedic |
| 2025-09-29 | K250023 | SMART PCFD | QIH | Class II | Radiology |
| 2024-07-02 | K240736 | SMART Bun-Yo-Matic X-Ray | QIH | Class II | Radiology |
| 2024-06-20 | K240642 | SMART Bun-Yo-Matic CT | QIH | Class II | Radiology |
| 2023-12-08 | K223757 | Bonelogic | QIH | Class II | Radiology |
| 2021-02-05 | K203290 | Bonelogic | LLZ | Class II | Radiology |