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The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system. Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy. The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters related to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing. The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV and broad electron beams from 4 to 30 MeV, delivered by standard medical linear accelerators (linacs). The software runs on a Windows XP, windows Vista and windows 7 systems (32 bit)

Oncentra Simulation is an accessory to a radiation therapy simulation system which is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

Oncentra Simulation 2.3 is a revision of the image handling software of the Simulix Evolution. This software has been adapted such that images can be acquired and processed from an Image Intensifier such as used on the Nucletron Radiotherapy simulators Simulix MC, Simulix HP and Simulix HQ. This makes it a replacement for the predicate device DTI (k954055). The PC based simulator workstation comes with functionality to support simulation procedures: Image acquisition, Image display, Image enhancement and multiple views, Database and DICOM Import / Export functionality, Simulator controls. The modification to the previously cleared device k033470 is: Added support for Image Intensifiers. The software runs on a PC on a Windows XP platform.

The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (k060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (k060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images. The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient. The devices are used as accessories to the Nucletron microSelectron Afterloaders

The Oncentra RT Viewer is intended to be used for review and evaluation of DICOM based patient data by qualified specialists. It is used to load and display data generated by different DICOM modalities including, but not limited to: RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET. It provides the user with a wide range of tools to compile, compare, and manipulate views and images. It enables super-positioning of geometrically related DICOM data.

RT Viewer provides tools for analysis of single and summed plans, and for comparison of several alternative plans. All image series and all RT objects (Structure Set, Plans, RT Images and Dose) in the study can be displayed and explored. RT Viewer is principally a read-only activity and produces no new data or modifications to the data for the study and the plan(s). Single Plan Evaluation - Display of plan dose in original, reconstructed planar and 3D images. - Display of dose as a sequence of objects, - Inspection and comparison of individual objects for a plan in a study. - Display of DVH in individual and total mode to view contributions from total plan or individual beams. - Display of DVH statistics. Plan Comparison - Side-by-side display of a plan for selected plans in a study, shown as a sequence of objects. - Comparison of DVH and dose statistics for plans in a study. Plan Summation - Summation of dose distributions for plans and display of summed dose. - Display of DVH in individual and total mode to view contributions from summed or individual plans. The software runs on a Windows XP or VISTA platform.

The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures.

The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced with the addition of nine guide holes in the ring tube (seven holes for part number 189.699). These guide holes allow placement of interstitial titanium needles using the ring tube as a needle template while still maintaining the treatment on the dose distribution. The addition of interstitial needles makes it possible to achieve asymmetric dose distributions around the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images.

The Oncentra MasterPlan system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

The Oncentra MasterPlan 3.1 system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments affer review and approval by qualified medical personnel. Oncentra MasterPlan 3.1uses externally acquired medical images and user input. The Oncentra MasterPlan 3.1software is based on a modular client/server design, with the treatment planning functions divided into "Activities". Oncentra MasterPlan 3.1 contains the following Activities: Anatomy Module: . The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) related to the patient anatomy and target volumes for treatment planning, The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized. · Beam Module The Beam Modelling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan. Connectivity Module: . The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external sources. Dose Module . The Dose Modelling (DM) module handles execution of External Beam dose calculations. Optimizer Module . The Oncentra Optimizer (OM) module handles execution of treatment plan optimization. This activity will result in an optimized treatment plan for which the final dose calculation must be performed by DM. Brachy Planning Module . The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. Evaluation Module: . The Evaluation Module (EM) handles the necessary tools for evaluating one treatment plan that has a calculated Dose result. EM supports the same tools as BM but in a read-only mode. Tools that are not read-only like new/delete beams, field shaping, edit MLC, apply/remove wedges, etc. are not supported in EM. Evaluator Module . The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The user may also select a candidate plan and approve the plan for treatment. The EVAL is a read-only activity with the exception of the plan approval function. · Volume Rendering The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module. In addition, various system utilities are available. The software runs on a Windows XP platform.

Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.

The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images. The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes. The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.

Oncentra GYN 1.0 is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.

Oncentra GYN is a "real time" treatment planning system for brachytherapy especially meant for the treatment of gynaecological cancers. Direct 3D imaging of the treatment area gives the physician the possibility to update the planning of the dwell positions of the radioactive source in the target volume of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, e.g. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The software is an adaptation of the software of the predicate device to make the software more suitable for the use with gynaecological cancers. The following features have been added for this: Support for applicators and needles (instead of only needles), 3D MRI, CT and ultra sound image import (instead of only ultra sound), Support of multiple target volumes (instead of only one), Optimisation algorithms more suitable for gynaecological treatments. The modified device is an accessory to a brachytherapy afterloader. The program consists of two modules: Treatment planning Software: Oncentra GYN, Database: Smoothbase. The software runs on a Windows XP platform on the same hardware as Swift 2.0.

EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy. The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters reliated to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing. The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV, delivered by standard medical linear accelerators (linacs), The software runs on a Windows XP platform.