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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.

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 Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

The Real-time Image Gating System for proton beam therapy (RGS) is a gating signal generator accessory to proton beam therapy systems (PBTS) and used to track an implanted fiducial and to control the proton beam. The RGS is installed on the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the X-ray imaging systems. The marker is implanted near the tumor using image guided implantation. Using two diagnostic X-ray sources and two X-ray FPDs configured around the treatment isocenter, the imaging data are combined to obtain precise 3D trajectories in the RGS. The RGS tracks the implanted marker on the image, and this chosen marker's position viewed in 3 dimensions. Using X-ray fluoroscopy devices in two distinct planes, the location of marker on the fluoroscopic image is automatically extracted using the pattern recognition technology of the RGS and the spatial position of the marker is calculated and monitored throughout the treatment. Synchronized irradiation of the tumor with gating control occurs only when the marker is within a given tolerance from its planned coordinates relative to the beam isocenter. This synchronized irradiation is performed at high speed which enables accurate irradiation of a tumor whose position may move inside the body, e.g., due to respiration.

ARIETTA Precision is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis.), Intra-operative (Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy .), Neonatal Cephalic, Adult Cephalic, Trans-rectal (Includes imaging for guidance of trans-rectal biopsy.), Trans-vaginal (Includes imaging for guidance of trans-vaginal biopsy.), Trans-esophageal (non-Cardiac - Adult/Pediatric), Musculo-skel. (Convent), Musculo-skel. (Superfic.), Other (spec.) -Wound (Includes imaging for Cavernous/Non-Cavernous wounds.), Other (spec) - Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac - Adult/Pediatric) and Peripheral vessel clinical applications. The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography) and TDI (Tissue Doppler Imaging), Trapezoid mode, Free Angular M mode.

The ARIETTA Precision is a compact ultrasound device that can be used by the patient bedside. Similar to the predicate: Arietta 70 cleared via K134016; the ARIETTA Precision is considered a "point of care" system that provides flexibility for patient scanning in any environment. This instrument can be used for individual or combined display in the image display modes listed below. - B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. - M mode is a display mode of ultrasound beams received sequentially and repeatedly on the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale. - There are two types of D (Doppler) mode and CW Doppler mode. PW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method. - Color Doppler mode receives ultrasound from the same direction and detects any changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need. The 5 methods of electronic scanning available on the ARIETTA Precision include: - Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. - Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. - Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. - Radial Scanning Method: By this method, the ultrasound probe emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject .. - Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the test subject.

ARIETTA Prologue is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of following clinical applications: FETAL; ABDOMINAL - (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis)); INTRA-OPERATIVE (SPEC.)-(Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)); INTRA-OPERATIVE (NEURO); LAPAROSCOPIC; PEDIATRIC; SMALL ORGAN (SPEC.)-(Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy): NEONATAL CEPHALIC: ADULT CEPHALIC; TRANS-RECTAL - (Includes imaging for guidance of trans-rectal biopsy); TRANS-VAGIAL -(Includes imaging for guidance of trans-vaginal biopsy); TRANS-ESOPHAGEAL (NON-CARDIAC & CARDIAC) -ADULT/PEDIATRIC; MUSCULOSKELETAL (CONVENT./SUPERFIC.); Other (spec.) -WOUND (Includes imaging for Cavernous/Non-Cavernous wounds); Other (spec) - GYNECOLOGICAL; CARDIAC: ADULT/ PEDIATRIC and PERIPHERAL VESSEL.

An ultrasound diagnostic system with the following features: - Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes - Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation - A computer system to control the transducer and analyze the signals resulting from the reflected echoes - A video monitor with optional image recorder to display the computed image or derived Doppler data

ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card), Adult Cephalic clinical applications. The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

An ultrasound diagnostic system with the following features: - Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes - Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation - A computer system - to control the transducer and analyze the signals resulting from the reflected echoes - A video monitor with optional image recorder to display the computed image or derived Doppler data

The PROBEAT-V with X-ray Limiting Accessory 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-V with X-ray Limiting Accessory 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 equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment. The X-ray Beam Limiting accessory for use in conjunction with the cleared PROBEAT-V system is designed to limit the patient's X-ray exposure during for patient positioning with the Cone Beam CT (CBCT). The device has 4 motorized leaves which are controlled by the PROBEAT-V imaging software to position the leaves in order to limit the patient's radiation exposure during patient positioning.

The PROBEAT-V 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-V includes optional accessories 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.

The PROBEAT-V 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 equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

The PROBEAT-V 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-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment. The beam delivery system is composed of the following components: - Gantry Room - Rotating Gantry - Scanning Nozzle - Patient Positioning System - Cone Beam CT / X-ray Imaging System - Fixed Beam Room - Scanning Nozzle - Patient Positioning System - Cone Beam CT The beam production system is composed of the following components: - Accelerator system (LINAC, Synchrotron) - Beam transport system (Low/High Energy Beam Transport systems)

The PROBEAT-V 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-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment. The beam delivery system is composed of the following components" - o Gantry Room - · Rotating Gantry - . Scanning Nozzle - . Patient Couch (or Patient Positioning System) - . X-ray Imaging System - o Fixed Beam Room - Scanning Nozzle . - . Patient Couch (or Patient Positioning System) - . X-ray Imaging System The beam production system is composed of the following components" - Accelerator system (LINAC, Synchrotron) O - Beam transport system (Low/High Energy Beam Transport systems) O