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

    STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100

    K Number: K081935 · Decision Oct 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    13
    Review Days
    92

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    Basic Information

    Device Name
    STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
    K Number
    K081935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aktina Medical Physics Corp.
    Date Received
    July 7, 2008
    Decision Date
    October 7, 2008
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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