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

    XPLAN 2.2 WITH THE BODY SYSTEM

    K Number: K013661 · Decision Dec 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    255
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    XPLAN 2.2 WITH THE BODY SYSTEM
    K Number
    K013661
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radionics, A Division of Tyco Healthcare Group LP
    Date Received
    November 6, 2001
    Decision Date
    December 3, 2001
    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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