Skip to contentDe Novo DEN250007
- Device
- Delivery Date AI
- Contact
- robert bunn
- De Novo number
- DEN250007
- Product code
- SHE
- Regulation
- 892.8200
- Classification name
- radiological software system for delivery date prediction
- Decision
- granted (DENG)
- Decision date
- 2026-02-11
- Date received
- 2025-03-17
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- SHE
- Device name
- Radiological Software System For Delivery Date Prediction
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.8200
- Implant
- N
- Life sustain/support
- N