SHE

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Radiological Software System For Delivery Date Prediction

Device class

Class II (moderate risk)

Regulation

21 CFR 892.8200

Medical specialty

Radiology

FDA 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.

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