Annalise Enterprise is an AI-enabled medical device from Harrison-AI Medical Pty, Ltd., listed by FDA (510(k), K253818) with a decision date of 2026-03-03. Review panel: Radiology.
| FDA submission number | K253818 |
|---|---|
| Pathway | 510(k) |
| Company | Harrison-AI Medical Pty, Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-03-03 |
| Decision | Substantially Equivalent |
| Product code | QAS |
| Classification | Radiological Computer-Assisted Triage And Notification Software |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 95 |
| Applicant country | AU |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.