DEN250007 is an FDA 510(k) submission for the Delivery Date AI. This device is classified as a Radiological Software System For Delivery Date Prediction (Class II - Special Controls, product code SHE).
Submitted by Ultrasound AI (Greenwood Village, US). The FDA issued a Not Cleared (DENG) decision on February 11, 2026.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.8200. A Radiological Software System For Delivery Date Prediction Is A Software-only Device That Analyzes Obstetric Radiological Images To Predict The Delivery Date Of A Pregnancy. The Device Output Does Not Replace A Clinician's Review Or Judgment On The Progression Of A Pregnancy And Should Be Used In Conjunction With Other Clinical And Diagnostic Findings. The Device Does Not Identify At-risk Pregnancies Or Identify Specific Complications..
| 510(k) Number | DEN250007 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 17, 2025 |
| Decision Date | February 11, 2026 |
| Days to Decision | 331 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | SHE - Radiological Software System For Delivery Date Prediction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.8200 |
| Definition | A Radiological Software System For Delivery Date Prediction Is A Software-only Device That Analyzes Obstetric Radiological Images To Predict The Delivery Date Of A Pregnancy. The Device Output Does Not Replace A Clinician's Review Or Judgment On The Progression Of A Pregnancy And Should Be Used In Conjunction With Other Clinical And Diagnostic Findings. The Device Does Not Identify At-risk Pregnancies Or Identify Specific Complications. |