# DEN250007: Delivery Date AI

- Pathway: De Novo (Direct)
- Applicant: Ultrasound AI
- Decided: Feb 11, 2026 after 331 days
- Product code: SHE (Radiological Software System For Delivery Date Prediction)
- Device class: 2
- Regulation: 21 CFR 892.8200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Delivery Date AI is a post-processing software designed to analyze pregnancy ultrasound images using machine learning techniques. It analyzes raw images to provide healthcare practitioners (HCPs) with a Predicted Delivery Date (PDD) in women without a reliable estimated delivery date. The software estimates the predicted delivery date for a singleton pregnancy and should be used as an aid in clinical judgment, alongside standard methods for assessing gestational age. This is a prediction of the actual delivery date called the Predicted Delivery Date (PDD). The software processes entire images, which include fetal and maternal characteristics, and targets a specific patient population consisting of women 18 years of age or older with a singleton pregnancy at or beyond 14 0/7 weeks through 36 6/7 weeks gestation who lack a reliable Estimated Delivery Date (EDD) due to: • Unreliable LMP: Examples include irregular menstrual cycles, spotting mistaken for menses, or recent use of hormonal contraceptives. • No First-Trimester Ultrasound: Absence of an ultrasound before 14 weeks gestation, precluding crown-rump length measurement. • Gestational Age Confirmation: Pregnancy within the indicated range verified by clinical indicators such as fundal height or detection of a fetal heartbeat.

Source page: https://510kreport.com/device/DEN250007
Methodology: https://510kreport.com/methodology