510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250007Unknown

Delivery Date AI

Ultrasound AI Inc., Greenwood Village CO / Direct, Unknown
FDA source (opens on fda.gov)

DEN250007 is the FDA 510(k) clearance record for Delivery Date AI, a class II device, cleared for Ultrasound AI on under FDA product code SHE (Radiological Software System For Delivery Date Prediction). FDA's definition for product code SHE reads: "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...". FDA records list one 510(k) clearance for Ultrasound AI. As of , FDA records show no recalls naming DEN250007.

Clearance record

Decision date
Received
(331 days to decision)
Product code
SHE Radiological Software System For Delivery Date Prediction
Regulation
21 CFR 892.8200
Device class
Class II
Review panel
Radiology
Applicant
Ultrasound AI 8400 E Crescent Pkwy., Greenwood Village CO
Third party review
No

Clearances, product code SHE

Trailing 12 months
1 clearance under product code SHE in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260