San Francisco, CA, US · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | Class II | Radiology | 4 | 2022-10-21 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 3 | 2025-06-10 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Class II | Radiology | 2 | 2023-03-17 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | Class II | Cardiovascular | 1 | 2023-08-03 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-06-10 | K250354 | Viz Subdural+, Viz SUBDURAL PLUS | QIH | Class II | Radiology |
| 2024-02-05 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | QIH | Class II | Radiology |
| 2023-08-03 | DEN230003 | Viz HCM | QXO | Class II | Cardiovascular |
| 2023-03-17 | K223443 | Viz AAA | QFM | Class II | Radiology |
| 2022-10-21 | K223042 | Viz LVO ContaCT | QAS | Class II | Radiology |
| 2022-08-29 | K221100 | Viz RV/LV | QIH | Class II | Radiology |
| 2022-07-25 | K220439 | Viz SDH | QAS | Class II | Radiology |
| 2022-02-18 | K213319 | Viz ANEURYSM, Viz ANX | QFM | Class II | Radiology |
| 2021-03-23 | K210209 | Viz ICH | QAS | Class II | Radiology |
| 2020-03-18 | K193658 | Viz ICH | QAS | Class II | Radiology |