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., Ischemaview, Inc. and Envisionit Deepai, Ltd..
FDA 510(k) Cleared Radiological Computer-assisted Prioritization Software For Lesions Devices (Product Code QFM)
About Product Code QFM - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code QFM since 2019, with 39 receiving FDA clearance (average review time: 160 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
Recent submissions under QFM have taken an average of 113 days to reach a decision - down from 170 days historically, suggesting improved FDA processing for this classification.
QFM devices are reviewed by the Radiology panel. Browse all Radiology devices →