DermaSensor is an AI-enabled medical device from DermaSensor Inc., listed by FDA (De Novo, DEN230008) with a decision date of 2024-01-12. Review panel: General and Plastic Surgery.
| FDA submission number | DEN230008 |
|---|---|
| Pathway | De Novo |
| Company | DermaSensor Inc. |
| Review panel (specialty) | General and Plastic Surgery |
| FDA decision date | 2024-01-12 |
| Decision | Unknown |
| Product code | QZS |
| Classification | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer |
| Device class | 2 |
| Regulation number | 878.1830 |
| Review time (calendar days) | 344 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All General and Plastic Surgery AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.