K-number	DEN250007
Device name	Delivery Date AI
Applicant	Ultrasound AI
Product code	SHE
Device class	Class II
Decision date	Feb 11, 2026
Decision	Not Substantially Equivalent
Regulation	—

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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