510(k) DEN250028
DEN250028 is an FDA 510(k) premarket notification submitted by Spectralmd, Inc. for the device "DeepView AI® System". The FDA issued a decision of De Novo Granted on May 21, 2026. The device falls under product code SHY (Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.), a Class II device regulated under 21 CFR 878.1840. Spectralmd, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 21, 2026
- Date Received
- June 27, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
- Device Class
- Class II
- Regulation Number
- 878.1840
- Review Panel
- SU
- Submission Type
A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device.