Skip to contentDe Novo DEN240047
- Device
- Allix5
- Contact
- kris zeschin
- De Novo number
- DEN240047
- Product code
- SEZ
- Regulation
- 892.8500
- Classification name
- radiological software device to predict future breast cancer risk
- Decision
- granted (DENG)
- Decision date
- 2025-05-30
- Date received
- 2024-09-06
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- SEZ
- Device name
- Radiological Software Device To Predict Future Breast Cancer Risk
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.8500
- Implant
- N
- Life sustain/support
- N