Product code SHY— General, Plastic Surgery
DeepView AI® System
- Classification name
- Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
- Device class
- Class 2
- Regulation
- 21 CFR 878.1840
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SHY
FDA has cleared device under product code SHY, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SHY
Recent clearances under product code SHY
Data sourced from openFDA. This site is unofficial and independent of the FDA.