DeviceClearance

Product code QFM— Radiology

BriefCase

Classification name
Radiological Computer-Assisted Prioritization Software For Lesions
Device class
Class 2
Regulation
21 CFR 892.2080
Advisory panel
Radiology
Total cleared
41
First cleared
Most recent

FDA classification definition

“Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.”

— U.S. Food and Drug Administration, device classification record for product code QFM under 21 CFR 892.2080, via openFDA

Market context for product code QFM

FDA has cleared 41 devices under product code QFM between 2019 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFM

Recent clearances under product code QFM

Data sourced from openFDA. This site is unofficial and independent of the FDA.