De Novo · Granted
GrantedDelivery Date AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrasound AI · SHE Radiological Software System For Delivery Date Prediction
Granted on Feb 11, 2026 as a new device type through De Novo after a 331-day review.
- Decided
- Feb 11, 2026
- Review
- 331 days
- Class
- Class II
- Product code
- SHE
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SHE devicesSHE Radiological Software System For Delivery Date Prediction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHE
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHE
Too few SHE 510(k)s in any year since 2007 to give a median.
Recalls per year · SHE
No recall names SHE since 2007.
Adverse event reports per year · SHE
No MAUDE report names SHE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (191 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250007 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250007: Delivery Date AI.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250007
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026