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

    GammaTile

    K Number: K180515 · Decision Jul 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    5
    Review Days
    129

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    Basic Information

    Device Name
    GammaTile
    K Number
    K180515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isoray Medical, Inc.
    Date Received
    February 27, 2018
    Decision Date
    July 6, 2018
    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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