BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇻🇳 Vietnam

    VinDr-Mammo

    K Number: K233108 · Decision May 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    239

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    Basic Information

    Device Name
    VinDr-Mammo
    K Number
    K233108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vinbigdata Joint Stock Company
    Date Received
    September 27, 2023
    Decision Date
    May 23, 2024
    Product Code
    QFM
    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
    QFM Radiological Computer-Assisted Prioritization Software For Lesions

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