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The EmpNia eMotus system is used to measure and record the patient's respiratory waveform to aid with respiratory-synchronized image acquisition or reconstruction during CT diagnostic imaging or radiation treatment planning procedures, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with organ position verification for radiation therapy treatment using CT or Xray imaging by monitoring the patient's respiratory waveform during the image acquisition, where there is a risk of respiratory motion compromising the resulting image. The EmpNia eMotus system is used to derive and communicate a Gate signal to aid with radiation therapy treatment, where there is a risk of respiratory motion compromising the resulting treatment accuracy.

The eMotus Respiratory Motion Management System ("eMotus system") is designed to monitor patient respiratory motion and to provide information about this respiratory motion to an external medical device system, such as a radiation therapy delivery device (TDD) or a diagnostic imaging device (DX). The main components of the eMotus system include: - Sensor pad with optical fiber sensors, - Optical fiber cables, - Optical transceiver, - Data acquisition computer with eMotus software application, - Communication modules for compatible external systems, and - Cables to allow data transmission between the components. The sensor pad is a single-use, disposable component with an adhesive backing that is placed directly on the patient's thorax or abdomen. The sensor pad is attached to optical fiber cables that connect to the optical transceiver, which collects optical signal data based on deflection of the sensors in response to respiratory motion. The transceiver digitizes the data and transmits it to the eMotus computer, which visualizes the data as a waveform that can be highlighted when the waveform amplitude reaches a user-specified threshold or the patient's respiratory cycle reaches a user-specified phase. The user can utilize the respiratory threshold and phase information to manually control an external TDD or DX system. When connected to an external TDD or DX, the eMotus system supports the following functions (as applicable given the functions of the external system): - **Threshold-gated therapy delivery:** Automatic gating (turning on / off) of the radiation treatment beam based on user-set parameters for the amplitude of the respiratory waveform. - **Phase-gated therapy delivery:** Automatic gating (turning on / off) of the radiation treatment beam based on user-set parameters for the phase of the respiratory waveform cycle. - **Retrospective four-dimensional planning scan:** Delivery of the respiratory waveform to an imaging device to synchronize the waveform data with the scan data, enabling retrospective four-dimensional reconstruction of the imaging session for use in treatment planning. - **Prospective four-dimensional planning scan:** Automatic patient's respiratory waveform are within preset limits, which is used to disable the radiation beam automatically. The eMotus device is an ancillary device and does not provide stand-alone therapy or diagnostic information.

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.

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.

The PROBEAT-FR 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.

The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site.

ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The ProBeam 360° Proton Therapy System v2.0 (Multiroom) is designed to deliver radiation treatment in accordance with the physician's prescribed treatment plan. Proton radiation therapy takes advantage of the Bragg peak characteristic of proton attenuation to minimize radiation of normal tissue outside the target volume. Varian markets two lines of proton therapy systems, the standard ProBeam Proton Therapy Systems and the smaller, newer ProBeam 360° Systems. The ProBeam 360° Proton Therapy System line of proton systems includes single-room (cleared in K221791) and multi-room configurations. The ProBeam 360° System Multiroom (subject device) introduces the multi-room, compact configuration and includes the following primary components: Cyclotron (226MeV), Beam Transport System (energy selection system and beam transport system), Two (2) to five (5) Treatment Rooms: Rotating Isocentric Gantry room with attached scanning nozzle; and a treatment table, One Treatment Control Room for each treatment room within the chosen configuration.

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.

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.

The Small Field Applicator is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system. The Small Field Applicator is composed of a cylinder part with touch sensors, a 4-legged table, and a plate part. The Small Field Applicator is inserted at the end of the nozzle to obtain a sharp lateral penumbra in the lateral dose distribution, and it can reduce the dose to the surrounding normal tissue than the case in which the Small Field Applicator is not used.

The ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, turnors, and conditions anywhere in the body where radiation treatment is indicated.

The ProBeam 360° Proton Therapy System is a device that generates ionizing radiation (protons) in order to deliver radiation therapy in accordance with a predetermined treatment plan. The ProBeam 360° System version 1.0 is available in single-room, compact configuration and includes the following primary components: Cyclotron, Beam Transport System, Treatment Room with a rotating Gantry, Treatment Control Room.

The intended use of the myQA iON product is to perform patient quality assurance activities for radiation therapy treatment delivery systems. myQA iON is a software toolbox allowing the Medical Physicist to perform quality assurance activities before and after the patient treatment fractions for all patients undergoing radiation therapy.

The myQA iON product is a server-based software application for performing patient quality assurance for radiation therapy. In its full scope, the product delivers means for the verification of: - The patient treatment plan prior to the first treatment fraction by - Using an independent dose algorithm to compute a dose map based on the patient treatment plan; - Performing measurements using external measurement devices and analyzing the results; - Performing machine log analysis during a treatment dry run session and reconstructing the delivered dose. - The patient treatment delivery by - Performing machine log analysis and reconstructing the delivered dose for each treatment fraction. In its full scope, the product interfaces with the Treatment Planning System, the Oncology Information System, the treatment delivery System and the external measurement device.

The PROBEAT-CR 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.

The PROBEAT-CR is a proton beam irradiation system. which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose. dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems: Beam production system (Accelerator system (LINAC. Synchrotron), Beam transport system (Low/High Energy Beam Transport systems)), Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a rotating gantry and 1 room will have a fixed beam. (Gantry Room (Scanning Nozzle, Rotating Gantry, Patient Positioning System, Orthogonal X-ray system, Cone Beam CT), Fixed Beam Room (Patient Positioning System, Orthogonal X-ray system, Treatment Control and Safety System)). The subject PROBEAT-CR is a modification to the cleared PROBEAT-CR to include the incorporation of the previously cleared Real Time Image Gating System for Proton Beam Therapy Systems ("RGS" or "RGPT") (K171049) for tracking implanted fiducials to qate the delivery of the proton beam, and the addition of an optional patient couch top extension as an accessory to allow for different patient positioning configurations.

The Aerial Couchtop for proton therapy is intended to support, position and immobilize patients during proton radiotherapy treatments.

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