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510(k) Data Aggregation

    K Number
    K191521
    Device Name
    Radiance 330 Proton Beam Therapy System
    Manufacturer
    ProTom International Holding Corporation
    Date Cleared
    2019-09-27

    (112 days)

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

    ProTom International Holding Corporation

    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 condition susceptible to treatment by radiation.
    Device Description
    The ProTom Radiance 330® is a medical device designed to produce and deliver a proton beam for the treatment of patients with solid tumors or other diseases susceptible for treatment by radiation. The device includes a method for delivering an accelerated proton beam to the treatment station. The device also includes equipment to position the patient and direct the beam angle. The system is comprised of six main subsystems that function in tandem to generate the desired dose level and distribution at the target site. - 1. Beam Production Subsystem. Produces a proton beam at the desired energy level - 2. Beam Transport Subsystem. Transports the beam from the Beam Production Subsystem to the Beam Delivery Subsystem - 3. Beam Delivery Subsystem. Monitors and steers the beam to the desired treatment location - Gantry Subsystem. Mechanically orients the Beam Transport and Beam Delivery Subsystems: providing a means of patient x-ray registration - 5. Patient Positioning Subsystem. Mechanically orients the patient; provide a separate and means of patient x-ray registration - Control Subsystem. Synchronizes the various subsystem actions and connects with hospital oncology information systems
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