SHY — Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. Class II
FDA product code SHY covers "Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.", a Class II medical device regulated under 21 CFR 878.1840. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHY
- Device Class
- Class II
- Regulation Number
- 878.1840
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250028 | spectralmd | DeepView AI® System | May 21, 2026 |