| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 5 | 2023-04-17 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | Class II | Radiology | 1 | 2026-04-29 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2025-09-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-29 | K253682 | DeepHealth ProstateAI | QDQ | Class II | Radiology |
| 2025-09-25 | K251527 | Brain WMH | QIH | Class II | Radiology |
| 2023-04-17 | K230772 | Quantib Prostate | LLZ | Class II | Radiology |
| 2022-05-13 | K221106 | Quantib Prostate | LLZ | Class II | Radiology |
| 2022-01-14 | K213737 | Quantib ND | LLZ | Class II | Radiology |
| 2020-10-11 | K202501 | Quantib Prostate | LLZ | Class II | Radiology |
| 2020-06-15 | K200899 | Quantib AI Node | LLZ | Class II | Radiology |