QFM — Radiological Computer-Assisted Prioritization Software For Lesions Class II

FDA Device Classification

Classification Details

Product Code
QFM
Device Class
Class II
Regulation Number
892.2080
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252482medcogneticsCogNet AI-MT+December 11, 2025
K250831annalise-aiAnnalise EnterpriseApril 23, 2025
K243808azmedRayvolve PTX-PEMarch 21, 2025
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K240612avicenna.aiCINA-VCFMay 31, 2024
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K232410milvueSmartChestMay 10, 2024
K231871envisionit deepaiRadify TriageJanuary 17, 2024
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K222268annalise-ai ptyAnnalise Enterprise CXR Triage TraumaMarch 28, 2023
K222179annalise-ai ptyAnnalise Enterprise CXR Triage TraumaMarch 28, 2023
K223443viz. aiViz AAAMarch 17, 2023
K230020aidoc medicalBriefCaseFebruary 1, 2023
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K222692aidoc medicalBriefCaseDecember 5, 2022
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K220080medcogneticsCogNet QmTRIAGESeptember 29, 2022