Product code SHE

Device name

Radiological Software System For Delivery Date Prediction

Medical specialty

Radiology

Device class

2

Regulation number

892.8200

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset