Delivery Date AI is an AI-enabled medical device from Ultrasound AI that the U.S. FDA granted through De Novo DEN250007 on February 11, 2026. Its lead review panel is Radiology and its primary product code is SHE (Radiological Software System For Delivery Date Prediction).
See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.
Key facts
| Submission number | DEN250007 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Ultrasound AI |
| Lead review panel | Radiology |
| Primary product code | SHE — Radiological Software System For Delivery Date Prediction |
| Applicant (openFDA) | Ultrasound AI |
| Applicant location | Greenwood Village, CO, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.8200 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Delivery Date AI went through this pathway (DEN250007).
openFDA lists it as a Class 2 device under 21 CFR 892.8200. Class II devices are moderate risk and are subject to general and special controls.
Product code SHE covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Ultrasound AI has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.