Data / Medical devices / United States / Ultrasound Ai Inc.
Ultrasound Ai Inc.: FDA-registered device maker in Highlands Ranch, CO, United States, 1 510(k) clearance
Ultrasound Ai Inc. is registered with the FDA (registration 3044467584) in Highlands Ranch, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044467584
- Address
- 4349 Ivycrest Pt, Highlands Ranch, CO, United States, 80130
- Owner or operator
- Ultrasound AI Inc. (10095554)
- Roles
- Manufacturer
- First device listed
- March 29, 2026
- Registered through
- 2026
- Brand names listed
- Delivery Date AI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Software System For Delivery Date Prediction | SHE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 11, 2026 | DEN250007 | Delivery Date AI | SHE | Unknown | Ultrasound AI | accessdata.fda.gov |
Updated February 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.