Annalise Enterprise is an AI-enabled medical device from Annalise-AI, listed by FDA (510(k), K250831) with a decision date of 2025-04-23. Review panel: Radiology.
| FDA submission number | K250831 |
|---|---|
| Pathway | 510(k) |
| Company | Annalise-AI |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-04-23 |
| Decision | Substantially Equivalent |
| Product code | QFM |
| Classification | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 35 |
| 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.