DeepView AI® System is an AI-enabled medical device from spectralmd, inc., listed by FDA (De Novo, DEN250028) with a decision date of 2026-05-21. Review panel: General and Plastic Surgery.
| FDA submission number | DEN250028 |
|---|---|
| Pathway | De Novo |
| Company | spectralmd, inc. |
| Review panel (specialty) | General and Plastic Surgery |
| FDA decision date | 2026-05-21 |
| Decision | Unknown |
| Product code | SHY |
| Classification | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. |
| Device class | 2 |
| Regulation number | 878.1840 |
| Review time (calendar days) | 328 |
| 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.