Somerville, MA, US · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | Class II | Radiology | 5 | 2026-06-15 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 3 | 2026-05-21 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2025-06-05 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Class II | Radiology | 1 | 2021-04-16 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-15 | K253825 | Saige-Dx | QDQ | Class II | Radiology |
| 2026-05-21 | K254131 | BAC | QIH | Class II | Radiology |
| 2025-08-11 | K251873 | Saige-Dx | QDQ | Class II | Radiology |
| 2025-06-05 | K243703 | TechLive | LLZ | Class II | Radiology |
| 2024-12-19 | K243705 | Saige-Density (2.5.0) | QIH | Class II | Radiology |
| 2024-12-19 | K243688 | Saige-Dx (3.1.0) | QDQ | Class II | Radiology |
| 2024-11-18 | K241747 | Saige-Dx | QDQ | Class II | Radiology |
| 2022-12-16 | K222275 | Saige-Density | QIH | Class II | Radiology |
| 2022-05-12 | K220105 | Saige-Dx | QDQ | Class II | Radiology |
| 2021-04-16 | K203517 | Saige-Q | QFM | Class II | Radiology |