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510(k) Data Aggregation

    K Number
    K134052
    Device Name
    RADIANCE 330 PROTON THERAPY SYSTEM
    Manufacturer
    ProTom International, Inc.
    Date Cleared
    2014-03-14

    (73 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ProTom International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProTom Radiance 330 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Device Description
    The Radiance 330 consists primarily of Beam Delivery and Beam Production systems. These systems are comprised of various components and/or accessories designed to produce and deliver a proton beam appropriate for patient treatment. The system components include: - Beam Production System. This system produces the proton beam and directs it to the appropriate treatment room and is comprised of the following subsystems: - Synchrotron subsystem. The accelerator unit is the source of the proton beam and is composed of the injector (which generates the proton beam) and the synchrotron (which accumulates, accelerates, and extracts the proton beam). - Beam Transport subsystem. This subsystem guides the proton beam extracted from the synchrotron to the treatment room. - Beam Delivery System. This system controls the irradiation dose and shapes the proton beam supplied through the beam transportation system into the configuration required for patient treatment, and directs the beam appropriately. It is comprised of the following subsystems: - Scan/Dose subsystem - Gantry subsystem - Patient Positioning subsystem. - Treatment Delivery Control subsystem
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