SHE

Radiological Software System For Delivery Date Prediction

Product code

SHE

Device name

Radiological Software System For Delivery Date Prediction

Device class

Class 2

21 CFR

21 CFR 892.8200

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-02-11.