DeepView AI® System— 510(k) DEN250028
UnknownSpectralmd, Inc.
FDA 510(k) clearance DEN250028 for DeepView AI® System, Unknown on 2026-05-21. Applicant: Spectralmd, Inc.. Device class: 2.
Summary
The DeepView AI System is from Spectralmd, filed under SHY, software-aided adjunctive diagnostic devices for use by healthcare providers in skin wound assessment.
Class II, 21 CFR 878.1840. General and Plastic Surgery is both the classification panel and the review panel. The record lists the submission type as Direct.
Spectralmd filed from Dallas, Texas. The decision date came 328 calendar days after the received date (June 27, 2025 to May 21, 2026).
Clearance details
- Applicant
- Spectralmd, Inc.
- Product code
- Product code SHY
- Device class
- Class 2
- Regulation
- 21 CFR 878.1840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Dallas, TX, US
More clearances from Spectralmd, Inc.
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