AI devices with FDA product code SHW — Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

Product code SHW (“Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Pathology panel (1). The most recent decision was ArteraAI Breast on May 4, 2026.