Clearance Summary
Delivery Date AI received FDA 510(k) clearance under submission number DEN250007, sponsored by Ultrasound AI. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-02-11.
- Submission: DEN250007
- Applicant / Sponsor: Ultrasound AI
- Clearance pathway: Direct
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.8200
- Decision date: 2026-02-11
Classification & Regulation
This clearance is catalogued under FDA product code SHE and 21 CFR 892.8200, within the Radiology review panel as a Class II device.