SHE · Class II · 21 CFR 892.8200

FDA Product Code SHE: 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.

Leading manufacturers include Ultrasound AI.

1
Total
0
Cleared
331d
Avg days
2026
Since

FDA 510(k) Cleared Radiological Software System For Delivery Date Prediction Devices (Product Code SHE)

1 devices
1–1 of 1
Not Cleared Feb 11, 2026
Delivery Date AI
DEN250007
Ultrasound AI
Radiology · 331d

How to use this database

This page lists all FDA 510(k) submissions for Radiological Software System For Delivery Date Prediction devices (product code SHE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →