DEN250007
- 510(k) number
- DEN250007
- Device name
- Delivery Date AI
- Applicant
- Ultrasound AI CO · US
- Product code
- SHE — Radiological Software System For Delivery Date Predi
- Decision date
- 2026-02-11
- Date received
- 2025-03-17
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Radiology
Official FDA record: DEN250007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.