SHY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.1840
- Medical specialty
- General, Plastic Surgery
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| DeepView AI® System (DEN250028) | Spectralmd, Inc. | 2026-05-21 |
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