DEN250028
- 510(k) number
- DEN250028
- Device name
- DeepView AI® System
- Applicant
- Spectralmd, Inc. TX · US
- Product code
- SHY — Software-Aided Adjunctive Diagnostic Device For Use
- Decision date
- 2026-05-21
- Date received
- 2025-06-27
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN250028
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.