Radiological Software System For Delivery Date Prediction
SHE · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.8200
Classification
FDA Product Code
SHE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.8200
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.