Devices · Ultrasound AI

Delivery Date AI

Ultrasound AI is listed for Delivery Date AI (DEN250007). The FDA list gives February 11, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SHE as “Radiological Software System For Delivery Date Prediction”: 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250007

Official FDA database record

Date of final decision

February 11, 2026

Company on the FDA list

Ultrasound AI

Lead panel

Radiology

Primary product code

SHE

openFDA device name for the code

Radiological Software System For Delivery Date Prediction

Device class

2

Regulation number

892.8200

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned