Skip to contentDe Novo DEN240068
- Device
- ArteraAI Prostate
- Contact
- candice bautista-biddle
- De Novo number
- DEN240068
- Product code
- SFH
- Regulation
- 864.3755
- Classification name
- pathology software algorithm device analyzing digital images for cancer prognosis
- Decision
- granted (DENG)
- Decision date
- 2025-07-31
- Date received
- 2024-11-25
- Classification advisory
- Pathology
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- SFH
- Device name
- Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
- Medical specialty
- Pathology
- Device class
- 2
- Regulation
- 864.3755
- Implant
- N
- Life sustain/support
- N