BEUDAMED
    Product Code: QFM FDA class 2 21 CFR 892.2080

    Radiological Computer-Assisted Prioritization Software For Lesions

    Radiology

    The 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 analysis of medical images, identifying or prioritizing time-sensitive imaging for review by prespecified clinical users based on software-based image analysis without providing diagnostic information beyond triage and notification. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 892.2080 in the Radiology specialty. The product code is QFM. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    40
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    27
    Years Active
    7

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    Basic Information

    Product Code
    QFM
    Device Class
    FDA class 2
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 40 510(k) clearances via K numbers.

    K Number Device Name
    K252954 MammoSightAI
    K252482 CogNet AI-MT+
    K250831 Annalise Enterprise
    K243808 Rayvolve PTX-PE
    K243548 BriefCase-Triage
    K241439 VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
    K240612 CINA-VCF
    K233108 VinDr-Mammo
    K232410 SmartChest
    K231871 Radify Triage
    K223754 BraveCX
    K230899 qXR-PTX-PE
    K230074 Rapid Aneurysm Triage and Notification
    K222268 Annalise Enterprise CXR Triage Trauma
    K222179 Annalise Enterprise CXR Triage Trauma
    K223443 Viz AAA
    K230020 BriefCase
    K221868 QOCA image Smart CXR Image Processing System
    K222692 BriefCase
    K221552 EFAI ChestSuite XR Pneumothorax Assessment System
    K220080 CogNet QmTRIAGE
    K222076 EFAI ChestSuite XR Pleural Effusion Assessment System
    K221241 DrAid for Radiology v1
    K214043 BriefCase
    K213566 ClearRead Xray Pneumothorax
    K213941 Annalise Enterprise CXR Triage Pneumothorax
    K213319 Viz ANEURYSM, Viz ANX
    K211803 HealthPPT
    K211733 Lunit INSIGHT CXR Triage
    K203517 Saige-Q
    K202992 BriefCase, RIB Fractures Triage (RibFx)
    K193271 uAI EasyTriage-Rib
    K200905 HealthMammo
    K192901 HealthVCF
    K193300 AIMI-Triage CXR PTX
    K191556 Red Dot
    K192320 HealthCXR
    K183182 Critical Care Suite
    K190362 HealthPNX
    K183285 cmTriage

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.