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510(k) Data Aggregation

    K Number
    K221996
    Device Name
    P-Cure Proton Beam Therapy System
    Manufacturer
    P-Cure Ltd.
    Date Cleared
    2023-03-20

    (257 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 P-Cure Proton Therapy System 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 in the head, neck and thorax.
    Device Description
    The P-CURE system 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 in the head, neck and thorax. The P-CURE proton beam therapy system comprises 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 seated patient; provides independent means of patient registration using CT (3D) and X-ray (2D) - CT system (P-ARTIS CT) - Robotic arm and chair (6 Degree of freedom Couch) (P-ARTIS PPS) - X-ray system (P-ARTIS XR) - Positioning Software (P-ARTIS SW) 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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    K Number
    K160611
    Device Name
    P-ARTIS
    Manufacturer
    P-CURE LTD.
    Date Cleared
    2016-08-08

    (158 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    P-CURE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.
    Device Description
    The P-ARTIS CT scanner is an adaptation of the cleared Philips AcQSim-Multislice-CT scanner (K033357, aka Brilliance Big Bore 16 Slice CT scanner) for imaging patients in a seated position. This adaptation is designed by P-Cure in agreement with Philips Medical Systems (Cleveland), Inc. P-Cure has developed a patient Chair and a wall mounted Sliding Platform that is responsible for moving the Gantry up and down along the center axis of the Gantry opening while the patient is seated. The Gantry motion serves to position the scan plane at the start of the region to be scanned and to increment the position of the scan plane during the scan itself. Being a modification of the cleared Philips AcQSim CT scanner, the principal mode of operation and the essential principles of operation are the same as those of the AcQSim CT scanner. A difference yet exists in the implementation of the scan plane incrementation: instead of moving the table with the lying patient In and Out of the scan plane, the P-ARTIS moves the Gantry scan plane Up and Down over the seated patient. The relative motion is however considered identical between the two systems.
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