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 Aidoc Medical , Ltd. and Ischemaview, Inc..
List of Radiological Computer-assisted Prioritization Software For Lesions devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Radiological Computer-assisted Prioritization Software For Lesions devices (product code QFM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →