BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

    K Number: K193602 · Decision May 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
    K Number
    K193602
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lv Liberty Vision Corporation
    Date Received
    December 23, 2019
    Decision Date
    May 29, 2020
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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