510(k) DEN250028 · SHY Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
DeepView AI® System
| Applicant | Spectralmd, Inc., Dallas TX, US |
| Decision | Unknown, May 21, 2026 |
| Received | Jun 27, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250028
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.