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

Product code SFH (“Pathology Software Algorithm Device Analyzing Digital Images For Prostate 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 Prostate on July 31, 2025.