Not Cleared Direct

DEN250007 - Delivery Date AI (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250007 · Ultrasound AI · Radiology device
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Feb 2026
Decision
331d
Days
Class 2
Risk

DEN250007 is an FDA 510(k) submission (not cleared) for the Delivery Date AI. Classified as Radiological Software System For Delivery Date Prediction (product code SHE), Class II - Special Controls.

Submitted by Ultrasound AI (Greenwood Village, US). The FDA issued a Not Cleared (DENG) decision on February 11, 2026 after a review of 331 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.8200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 331 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ultrasound AI devices

Submission Details

510(k) Number DEN250007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 17, 2025
Decision Date February 11, 2026
Days to Decision 331 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 107d · This submission: 331d
Pathway characteristics

Device Classification

Product Code SHE Radiological Software System For Delivery Date Prediction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.8200
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.