QFM

Radiological Computer-Assisted Prioritization Software For Lesions

Product code

QFM

Device name

Radiological Computer-Assisted Prioritization Software For Lesions

Device class

Class 2

21 CFR

21 CFR 892.2080

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

12

Summaries archived here

12 (direct download)

510(k) clearances (all years, FDA)

41 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (12)

Last three years. Most recent: 2026-07-08.

12 summaries are archived here for direct download.