Delivery Date AI— 510(k) DEN250007
UnknownUltrasound AI
FDA 510(k) clearance DEN250007 for Delivery Date AI, Unknown on 2026-02-11. Applicant: Ultrasound AI. Device class: 2.
Summary
Ultrasound AI's Delivery Date AI is filed under product code SHE (Radiological Software System For Delivery Date Prediction). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.8200. Radiology is both the classification panel and the review panel. The record lists the submission type as Direct.
Ultrasound AI filed from Greenwood Village, Colorado. The decision date came 331 calendar days after the received date (March 17, 2025 to February 11, 2026).
Clearance details
- Applicant
- Ultrasound AI
- Product code
- Product code SHE
- Device class
- Class 2
- Regulation
- 21 CFR 892.8200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Greenwood Village, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.