BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    QFR (3.0)

    K Number: K243769 · Decision Apr 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    119

    Basic Information

    Device Name
    QFR (3.0)
    K Number
    K243769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    QFR Solutions bv
    Date Received
    December 6, 2024
    Decision Date
    April 4, 2025
    Product Code
    QHA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QHA X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

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