FDA Registration
Active
🇺🇸 United States
ULTRASOUND AI INC.
Reg #: 3044467584
·
FEI: 3044467584
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ULTRASOUND AI INC.
- Registration Number
- 3044467584
- FEI Number
- 3044467584
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4349 Ivycrest Pt
- City
- Highlands Ranch
- State
- CO
- ZIP
- 80130
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN250007
Owner / Operator
- Firm Name
- Ultrasound AI Inc.
- Operator Number
- 10095554
- Address
- 4349 Ivycrest Pt
- City
- Highlands Ranch
- State
- CO
- Postal Code
- 80130
- Country
- US
- Correspondent
- Robert Bunn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Software System For Delivery Date Prediction | SHE | Class 2 | Radiology | No | 2026-03-29 |
Proprietary Names
Delivery Date AI
Establishment Types
Manufacture Medical Device