| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | Class II | Radiology | 5 | 2026-06-26 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 2 | 2025-08-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-26 | K260714 | MammoScreen® (5) | QDQ | Class II | Radiology |
| 2025-08-22 | K243685 | MammoScreen BD | QIH | Class II | Radiology |
| 2025-07-03 | K243679 | MammoScreen® (4) | QDQ | Class II | Radiology |
| 2024-10-02 | K241561 | MammoScreen BD | QIH | Class II | Radiology |
| 2024-08-01 | K240301 | MammoScreen® (3) | QDQ | Class II | Radiology |
| 2021-11-26 | K211541 | MammoScreen 2.0 | QDQ | Class II | Radiology |
| 2020-03-25 | K192854 | MammoScreen | QDQ | Class II | Radiology |