510(k) DEN250007
- Device
- Delivery Date AI
- Applicant
- Ultrasound AI
- 510(k) number
- DEN250007
- Product code
- SHE
- Decision
- Unknown (DENG)
- Decision date
- 2026-02-11
- Date received
- 2025-03-17
- Regulation
- 892.8200
- Classification name
- Radiological Software System For Delivery Date Prediction
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Robert Bunn
- Address
- 8400 E Crescent Pkwy. Suite 640 Greenwood Village CO US 80111 80111
FDA Registration Numbers
- 3044467584
Source Documents
510(k) summary PDF not indicated by FDA