510(k) DEN250007
DEN250007 is an FDA 510(k) premarket notification submitted by Ultrasound AI for the device "Delivery Date AI". The FDA issued a decision of De Novo Granted on Feb 11, 2026. The device falls under product code SHE (Radiological Software System For Delivery Date Prediction), a Class II device regulated under 21 CFR 892.8200.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Feb 11, 2026
- Date Received
- Mar 17, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Software System For Delivery Date Prediction
- Device Class
- Class II
- Regulation Number
- 892.8200
- Review Panel
- RA
- Submission Type
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.