AI devices with FDA product code SHY — Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

Product code SHY (“Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the General and Plastic Surgery panel (1). The most recent decision was DeepView AI® System on May 21, 2026.