Sydney, AU · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | Class II | Radiology | 4 | 2023-09-22 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Class II | Radiology | 2 | 2023-03-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-09-22 | K231767 | Annalise Enterprise CTB Triage Trauma | QAS | Class II | Radiology |
| 2023-09-22 | K231384 | Annalise Enterprise CTB Triage Trauma | QAS | Class II | Radiology |
| 2023-08-15 | K231094 | Annalise Enterprise CTB Triage-OH | QAS | Class II | Radiology |
| 2023-04-03 | K223240 | Annalise Enterprise CTB Triage Trauma | QAS | Class II | Radiology |
| 2023-03-28 | K222268 | Annalise Enterprise CXR Triage Trauma | QFM | Class II | Radiology |
| 2023-03-28 | K222179 | Annalise Enterprise CXR Triage Trauma | QFM | Class II | Radiology |