AI devices with FDA product code QPN — Software Algorithm Device To Assist Users In Digital Pathology

Product code QPN (“Software Algorithm Device To Assist Users In Digital Pathology” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Pathology panel (2). The most recent decision was Galen™ Second Read™ on January 24, 2025.