510(k) DEN250007

Delivery Date AI by Ultrasound AI — Product Code SHE

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 11, 2026
Date Received: March 17, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Radiological Software System For Delivery Date Prediction
Device Class: Class II
Regulation Number: 892.8200
Review Panel: RA
Submission Type

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.