Radiology · De Novo · 2026
Delivery Date AI
Ultrasound AI. Granted by FDA on 11 February 2026 under submission DEN250007, product code SHE (radiological software system for delivery date prediction). What FDA's record says, in FDA's words.
Device record · DEN250007
- Device. Delivery Date AIDEVICE
- Company. Ultrasound AICOMPANY
- Decision. 11 February 2026, De NovoDECISION
- Panel. RadiologyPANEL
- Product code. SHE, Radiological Software System For Delivery Date PredictionCODE
- Regulation. 21 CFR 892.8200, Class IIREG
- Source. FDA database entry · decision document (6 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
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. DEN250007 - Raymond Kelly Page 2 • Gestational Age Confirmation: Pregnancy within the indicated range verified by clinical indicators such as fundal height or detection of a fetal heartbeat. FDA concludes that this device should be classified into Class II. This order, therefore, classifies the Delivery Date AI, and substantially equivalent devices of […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SHE, in Radiology, or granted in 2026. The whole record is at FDA AI-enabled medical devices.
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