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BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

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The nomosSTAT device is intended to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy syment.

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The nTRAK Patient Positioning and Monitoring System is Intended for use with a linear accelerator in Radiation Therapy(RT)/ stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.

The Navigator System utilizes a high resolution optical tracking system to determine and monitor the position of optical markers attached to the patient as the means to locate and monitor the position and orientation of the patient, relative to treatment isocenter. The Navigator System consists of the following major components: a. A high resolution optical camera array and illuminator. b. A computer workstation. c. An optical positioning device. d. An optical calibration device.

The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification. The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machinespecific data and are intended to provide a quide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist. The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist. The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported. The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.

The NOMOS Motorized CRANE II is intended to be used as an accessory to powered radiation therapy patient support tables. The NOMOS Motorized CRANE II verifies and describes, via a set of Z and X coordinates, the set-up of the table/patient prior to treatment.

The NOMOS Motorized CRANE II is a powered version of the manual NOMOS CRANE II. It is an accessory to radiation therapy patient support tables. Like the NOMOS CRANE II, the Motorized CRANE II attaches to the stationary base Elle the NOWOO OF through a permanently installed interface plate and clamps to the accessory rails of the moveable table top. The Motorized CRANE II can be the acod from the treatment table when its use is not required, leaving only the interface plate remaining on the stationary base of the treatment table. The Motorized CRANE II uses precision ball screw drive positioning mechanisms (one for the Z-axis and one for the X-axis) to position the table top relative to the stationary base of the treatment table. While these positioning mechanisms retain the small hand cranks employed in the predicate CRANE II to allow manual operation when needed, the primary drive force is provided by two electric motors – one for each axis of movement. These motors le provided and operator interface is provided through two touch screen are ooltware oon. One located on the device and one remote panel that can be placed in the treatment control room. The control panels display the position of the patient treatment table, and allow the operator to specify and initiate movement in the Z and X axes. Using the NOMOS CRANE II, the operator can move the treatment table over a range of 300 mm in each axis. When attached to a treatment table loaded to a maximum weight of 300 ounds, the NOMOS Motorized Crane II is capable of +/- 0.1 mm accuracy in the Zaxis, and +/- 0.4 mm accuracy in the X-axis. The Motorized CRANE II retains the battery-powered digital scales from the Crane II as an independent means of position verification.

The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used for radiation therapy in conjunction with a Radiation Treatment Planning system to calculate dose distributions. It is to be used by the physician and/or other competent health aooo alombation clinical review and judgement of radiation treatment plans. The goal of the protections is to produce consistent highly accurate dose calculations using the Monte Carlo algorithms. The PEREGRINE™ Radiation Therapy Dose Calculation System is used in conjunction with a radiation treatment planning system to provide the dose distribution for radiation therapy treatments employing radiation sources and associated beam modifiers for clinical review and judgement prior to treating the patient. The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, or dosimetrist.

The PEREGRINE Radiation Therapy Dose Calculation System is a 3-D Monte Carlo radiation transport system designed to provide accurate dose calculations for radiation therapy treatment planning. PEREGRINE combines Monte Carlo-based modeling of the accelerator beam production system, Monte Carlo simulation of treatment-specific beam modifiers and Monte Carlo transport in the patient to provide a robust and accurate representation of the radiation source, beam modifiers and heterogeneities in the patient. PEREGRINE has been designed to provide highly accurate, high resolution radiation dose calculations rapidly on economical, commercially available computer microprocessors and to be easily integrated with commercial radiation treatment planning systems. In order to ensure its accuracy, PEREGRINE has been verified against a comprehensive set of clinical measurements designed to stress the physics algorithms for a full range of clinically relevant materials, densities and beam energies for open, blocked, wedged and compensated fields incident on both simple phantoms and phantoms with a variety of surface and sub-surface heterogeneities.

The RAPTOR® Radiation Treatment Planning System is intended to be used by radiation oncology professionals for clinical review and judgement of radiation treatment plans and dose estimates based on computation, output and displays. The goal of the system is to produce consistent results using well-documented algorithms. It will provide outputs for radiation delivery equipment including documented and released multileaf collimators [MLCs] for planning, optimization, delivery and reporting of treatments. The device provides output data in the form of displays, hardcopy prints and / or plots, set-up instructions and other control information to guide the physician and / or other competent health care professional in selecting the optimum patient treatment plan. The RAPTOR® Treatment Planning System is used to generate computation, display, evaluation and output radiation dose estimates for clinical review and judgement prior to treating the patient. It uses well-documented algorithms to provide output data in the form of displays, hardcopy prints, plots and treatment instructions to guide the radiation oncology professional and / or physician to select the optimum treatment plan. The MLC module is used to generate plans and instructions for documented and released multileaf collimators.

The RAPTOR Treatment Planning System is a collection of software modules that execute known and documented algorithms to produce radiation dose estimations. All data is user controlled and is a table look-up formation is presented graphically on CRT screens and hardcopy reports. Various models are available based on the specific features desired by the customer (e.q., asymmetric jaws, electron pencil beam calculations, etc.) to best meet their clinical needs. The software is designed to run on a PC platform utilizing the Microsoft Windows NT® operating system. The RAPTOR Treatment Planning System includes modules for the development of instructions and controls for multileaf collimators. It is designed to upgradable in both hardware and software features. All dates are four digit numbers so the system is year 2000 compliant.

The NOMOS® CRANE II is intended to be used as an accessory to powered, radiation therapy patient support assemblies. The CRANE II verifies and describes, via a set of X, Y and Z coordinates, the set-up of the couch/patient prior to treatment.

The NOMOS CRANE II is an accessory to powered radiation therapy patient support assemblies. The NOMOS CRANE II attaches to the stationary base of the treatment table through a permanently installed interface plate and clamps to the accessory rails of the moveable couch top. A treatment table foot brake is also installed, if not already part of the treatment table, to further stabilize the stationary base. The treatment table foot brake is typically an accessory that can be purchased from the treatment table original equipment manufacturer (OEM). In cases where the foot brake is not an OEM accessory, one will be adapted or custom designed for the application. The CRANE II can be removed from the treatment table with only the interface plate remaining on the stationary base of the treatment table. The CRANE II uses precision ball screw drive positioning tables, one for the Y-axis and one for the X-axis, to position the couch top relative to the stationary base of the treatment table. The positioning tables are operated using a small hand crank. Each axis of the CRANE II incorporates a battery powered digital scale that measures the movement of the positioning table and therefore, the movement of the couch top itself. The digital scale may be set to display the value in inches, however, the operator's manual instructs the user to set the digital scale to display millimeters With the CRANE II attached, the couch top can be manipulated over a range of 12 inches (304.8 mm) in both the Y and X axis with no impedance on the couches range of travel in the Z-axis.

BAT is intended for use in external beam Radiation Therapy (RT)/Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for the delivery of conformal radiation. BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.

BAT permits its user to align the isocenter crosshairs, structure contours or calculated dose (the latter 2 imported from a treatment planning system) with perpendicular ultrasound images acquired at treatment time. The BAT system then guides couch motion to achieve the desired patient alignment with the treatment beam. Additional ultrasound images can be taken to confirm proper positioning.

The NOMOS Slit Collimator (BEAK™) is intended for use in Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® Multileaf Intensity Modulating Collimator (K940412). Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

The Slit Collimator (BEAK) is tungsten block whose purpose is to provide secondary collimation for the radiation beam exiting from the NOMOS MIMiC (K940412). The MIMiC has the capability of delivering treatment slices whose width is either 8 mm or 16 mm. The Slit collimator, by providing secondary collimation of the 8 mm beam, allows slices to be delivered that are 1 - 8 mm in thickness without the need to modify the control mechanisms built into the MIMiC that ensure that leaf (vane) movement is functioning correctly. In this sense, the Slit Collimator serves the same purpose as the secondary collimators provided with radiosurgical systems or the secondary collimators, commonly called blocks, that are used with radiation therapy linear accelerators.