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

    CONTOURING DEVICE

    K Number: K920506 · Decision Oct 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    252

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    Basic Information

    Device Name
    CONTOURING DEVICE
    K Number
    K920506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    X-Icon Medical Systems
    Date Received
    February 5, 1992
    Decision Date
    October 14, 1992
    Product Code
    KPQ
    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
    KPQ System, Simulation, Radiation Therapy

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