FDA Product Code QFM: Radiological Computer-assisted Prioritization Software For Lesions

Under FDA product code QFM, radiological computer-assisted prioritization software is cleared to help manage imaging workflow by ranking cases by clinical urgency.

These AI-powered tools analyze radiological images and assign priority scores based on the probability of actionable findings, ensuring that the most critical cases are reviewed first. Unlike triage-and-notify systems, QFM devices focus on workflow optimization across the entire reading queue.

QFM devices are Class II medical devices, regulated under 21 CFR 892.2080 and reviewed by the FDA Radiology panel.

Leading manufacturers include Zebra Medical Vision, Ltd., Aidoc Medical , Ltd. and Annalise-Ai.