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510(k) Data Aggregation

    K Number
    K242418
    Device Name
    P-Cure Proton Therapy System (PPTS)
    Manufacturer
    P-Cure, Ltd.
    Date Cleared
    2025-05-12

    (270 days)

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

    P-Cure, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PPTS 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. When the patient is in the seated position using the chair, the System is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the head, neck and thorax.
    Device Description
    The P-CURE Proton Therapy System (PPTS) is comprised of four main subsystems that function in tandem to generate the desired dose level and distribution at the target site: - Beam production system (Synchrotron based accelerator) - Injector – produces and delivers protons to the synchrotron - Synchrotron ring – accelerates the proton beam in circular orbit (within the ring) to the desired energy level - Extraction system - extracts the beam from the ring to the beam delivery subsystem - Beam delivery system for a single fixed beam treatment room. Steers and monitors the extracted proton pencil beam from the synchrotron to the desired treatment location (Nozzle). - Patient Positioning System (P-ARTIS). Mechanically orients the patient (seated or on supine); provides independent means of patient registration using CT (3D) and X-ray (2D) - CT system (P-ARTIS CT) - Robotic arm and chair/couch (6 Degree of freedom Couch) (P-ARTIS PPS) - X-ray system (P-ARTIS XR) - Positioning Software (P-ART) - Control and Safety Systems - Control Subsystem (TSM). Synchronizes the various subsystem actions and connects with hospital oncology information systems and PACS. - Safety Subsystem. Includes hardware and software means to ensure safe system operation for patient and personnel. It includes subsystem interlocks, treatment beam parameters monitoring, and others.
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