Radiology
Delivery Date AI
Ultrasound AI
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.
FDA Submission Metadata
- Submission number
- DEN250007
- Decision date
- February 2026
- FDA panel
- Radiology
- Product code
- SHE
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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