DeviceClearance

Product code SHE— Radiology

Delivery Date AI

Classification name
Radiological Software System For Delivery Date Prediction
Device class
Class 2
Regulation
21 CFR 892.8200
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SHE under 21 CFR 892.8200, via openFDA

Market context for product code SHE

FDA has cleared 1 device under product code SHE, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHE

Recent clearances under product code SHE

Data sourced from openFDA. This site is unofficial and independent of the FDA.