AI devices with FDA product code QWO — Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Product code QWO (“Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.” in openFDA) covers 4 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Radiology panel (4). The most recent decision was Fibresolve (with PCCP) on November 7, 2025.