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
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

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

About Product Code SHE - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SHE since 2026, with 0 receiving FDA clearance (average review time: 331 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SHE devices are reviewed by the Radiology panel. Browse all Radiology devices →