BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    LEKSELL GAMMAPLAN

    K Number: K103093 · Decision Dec 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    51
    Same Product Code
    243
    Applicant Total
    30
    Review Days
    63

    Basic Information

    Device Name
    LEKSELL GAMMAPLAN
    K Number
    K103093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ELEKTA INSTRUMENT AB
    Date Received
    October 19, 2010
    Decision Date
    December 21, 2010
    Product Code
    MUJ
    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
    MUJ System, Planning, Radiation Therapy Treatment

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