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The DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

The device is a transportable Electromagnetic Extracorporeal Shock Wave Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem. Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices. The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.

Pronex is used to position a patient for prone breast radiation therapy.

The device comprise two rigid mechanical structures, each incorporating: * A tabletop for supporting a patient's torso in the prone position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical. * A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment. The imaging-oriented supporting structure is CT radiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position. The respective couches provide positioning motion. The intended use, functionality, technological characteristics and materials of the device are similar to those of the predicate devices.

TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system

TrackPort

TrackLeaf-10 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. TrackLeaf-10 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments.

TrackLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used in radiation treatment. It enables shaping the Linac beam according to target geometrical and clinical requirements. The device is composed of the MMLC modules the Linac interface modules the v Workstation (with TrackLeaf. Control. Software), and the Power Distribution module. » The device operates in conjunction with a Linac, a treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required in radiation treatment. In addition, means are provided to receive aperture offset data from an Image Guided Radiation Therapy (IGRT) system in order to perform leaves position adjustments. MMLC apertures are generated by positioning the motor-driven leaves. TrackLeaf software operates as a sequential process of forming apertures. TrackLeaf operation modes are: Step-and-Shoot, Dynamic Arc, and dynamic IMRT (DIMRT). - Step-and-Shoot: TrackLeaf forms apertures while irradiation is off and gantry is stationary. - Dynamic Arc: TrackLeaf forms apertures while irradiation is on and the gantry rotates. - DIMRT: TrackLeaf forms apertures while irradiation is on and the gantry is stationary.

Accusoft-XL v.4.04 / CrossPlan is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. CrossPlan / AccuSoft-XL v. 4.04 is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. CrossPlan / AccuSoft-XL v. 4.04 is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) - in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images. CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.

Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

Integra SL is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of a Shock Wave Generator (SWAG), a Urological Table (UT) and the remote controls. Integra SL also contains the necessary interfaces for fluoroscopic and (or) ultrasonic imaging devices. The device has no Software control. Integra SL includes the following features: - EM Shockwave generator with parabolic reflector for focusing mechanism - Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations). - A stand alone UT unit - Modular construction

AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radia fon therapy.

AccuSoft-XL is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. AccuSoft-XL is an upgraded version of the Company's proprietary AccuSoft v3.14. It is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular, shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. AccuSoft-XL is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) – in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation The Linac and Cones / MMLC configuration parameters shall be written to a file to be sent to both the Linac and the Company's proprietary Cone Changer / MMLC devices. In the AccuFusion module, AccuSoft-XL combines two different types of axial images. This enables to enhance the display of various materials or tissues and to perform target delineation on fused images. Thus, CT images and Secondary Images (CT, MRI, PET, etc.) in DIOOM format from the same patient can be combined, resulting in an improved single image.

Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.

Vert-X is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. Vert-X acquires, processes, displays, and stores x-ray images, for image diagnosis.

MAGIS1 / MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures

MAGIS1 and MAGIS21 are self-supported, added-on mobile imaging systems incorporating one or two X-ray channels respectively. MAGIS is mechanically coupled to the Linac Gantry and the couch, and is capable of rotating with both. MAGIS acquires and processes stereoscopic images for deriving localization data, in the form of discrepancy between planned and actual object position. Localization methods include markers trianqulation and DRR comparisons to acquired images. MAGIS incorporates X-ray production and detection modules mounted on extension arms attached to a Ring. The ring has a bore large enough to accommodate a patient and is operable to rotate about a horizontal axis, whereas said axis is parallel to couch direction and intersecting the isocenter. MAGIS also incorporates a Console for user interface and for accommodation of the image acquisition, processing, display and user interface equipment.

MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.

MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures. The device consists of three units: 1. MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images. 2. Console Workstation PC with embedded software, used for control, display and image processing. 3. Electronics Cabinet. Principle of operation: a) Acquire two images, one from each channel. b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.