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    K Number
    K063691
    Device Name
    NEUTRON THERAPY SYSTEM
    Manufacturer
    NORTHERN ILLINOIS UNIV. OUTREACH
    Date Cleared
    2007-01-31

    (50 days)

    Product Code
    IWL
    Regulation Number
    892.5300
    Why did this record match?
    Product Code :

    IWL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIUINT at Fermilab NTS is a preamendments medical device designed to produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Device Description
    The modified NTS is a medical neutron radiation therapy system that provides a therapeutic neutron beam for clinical treatment. Modifications include upgrades to the Patient Treatment Chair Subsystem, the Patient Treatment Platform Subsystem, the GE CT/T 8800 Scanner Subsystem, and the Patient Treatment Simulation Software Subsystem.
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