Delivery Date AI is an AI-enabled medical device from Ultrasound AI, listed by FDA (De Novo, DEN250007) with a decision date of 2026-02-11. Review panel: Radiology.
| FDA submission number | DEN250007 |
|---|---|
| Pathway | De Novo |
| Company | Ultrasound AI |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-02-11 |
| Decision | Unknown |
| Product code | SHE |
| Classification | Radiological Software System For Delivery Date Prediction |
| Device class | 2 |
| Regulation number | 892.8200 |
| Review time (calendar days) | 331 |
| Applicant country | US |
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.