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

    PROTON THERAPY SYSTEM

    K Number: K062891 · Decision Dec 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    79

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    Basic Information

    Device Name
    PROTON THERAPY SYSTEM
    K Number
    K062891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Indiana University Cyclotron Facility
    Date Received
    September 26, 2006
    Decision Date
    December 14, 2006
    Product Code
    LHN
    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
    LHN System, Radiation Therapy, Charged-Particle, Medical

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