De Novo DEN250028
- Device
- DeepView AI® System
- Contact
- trudy estridge
- De Novo number
- DEN250028
- Product code
- SHY
- Regulation
- 878.1840
- Classification name
- software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment.
- Decision
- granted (DENG)
- Decision date
- 2026-05-21
- Date received
- 2025-06-27
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct