Search Results

AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist nuclear medicine physicians and trained healthcare professional) to assist treatment planning. AdvantageSim MD with MR pelvic organ at risk segmentation Option is used to provide MR based prostate and pelvic organs-at-risk segmentation. A suite of semi-automated MR based organ segmentation contouring allows generating complex structures around organs at risk. These contours overlay on the co-registered CT planning image. The segmentation methods in the modified device are semi-automatic. The user has to place seed points to identify an inner point of the organ to contour. The software offers a suite of manual contour editing tools enabling the user to edit, modify, or change contours generated from the MR segmentation tools to their desired configuration based on their medical and clinical knowledge and experience. The results provided by the software needs to be approved by the experienced clinician and can always be modified or corrected by him/her. It is up to the expert user to accept the result without any change, reject it completely and delineate manually, or modify the result and then save it. The software does not provide any auto-detection or auto-saving functionalities. Same as the predicate devices, the clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images, regardless of the accuracy of the output generated by the software.

AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist, nuclear medicine physicians and trained healthcare professional) to assist treatment planning.

1. Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer. 2. Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices. 3. The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device. 4. The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist. 5. The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist. 6. The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

The RAD II KV Imaging device is mounted directly to the head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.

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 IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

The IKOEngelo version 2.0 device is a software system upgraded from version 1.0. This submitted new version has better contour modification tool, faster image files loading and display, and a new function for image fusion. For the same purpose of version 1.0, this software will assist radiation oncologists with the assistance of physicists and dosimetrists to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images.

The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.

Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347). The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software. The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system. The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm. The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality: - . Image acquisition - Image display . - Image annotation . - Database and DICOM Import / Export functionality - Position read out and display of the IBU-D gantry. . - Control of the IBU-D beam limiting device. .

The IKOEngelo™ System is intended for use in tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The IKOEngelo™ System is indicated for use by radiation oncologists, medical physicists, and medical dosimetrists for tumor and normal tissue contour delineation to support the radiotherapy treatment planning process. The resulting information may then be exported to a treatment planning system for dose calculation.

The IKOEngelo device is a software system that will assist radiation oncologists, with the assistance of physicists and dosimetrists, to more efficiently perform contour delineation of the tumor target and normal tissue on patient's CT images. The sequence of events is illustrated in the following bullet items and diagram: - Import patient's CT images. . - Select the proper Expert Case (including the CT image data set and . contours) to match patient's CT. - Automatically fuse the images to align patient's CT image data sets . with those of the Expert Case. - Run deformable segmentation to auto-contour on the patient's CT . images. - Review patient's contours and modify them if necessary. . - Approval by qualified radiation oncologist. . - Export patient's CT with its contours to the treatment planning system . used by the facility.

Simulix Evolution is a radiation therapy simulation system 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. The Ocentra Cone Beam CT option for the Simulis Evolution Radiotion Therapy Simulator is intended to assist the Radiation Oncologist in acquiring 3D "multi slice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning

Oncentra ConeBeam is an extension to the Nucletron Simulix Evolution system. The Simulix Evolution is a Radiation Therapy Simulation System which is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied. The Simulix Evolution is previously cleared under 510(k) #k033470. The Oncentra ConeBeam extension will give the Simulix Evolution system the capability to acquire Computer Tomography (CT) images. This is done by means of scanning the patient with a cone shaped X-ray beam. The cone shaped beam gives the possibility to acquire CT image information of a volume instead of CT image information of a single slice as with conventional fan beam CT. The images acquired with Oncentra ConeBeam will be used for the purpose of radiation therapy planning and to check the positioning of the patient.

AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph. The GE Advantage Sim MD has to ensure relations with the following external systems: Data Export, Marking Systems, RT Data Import, Hardcopy, Archiving.

Simulix Evolution is a radiation therapy simulation system 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.

Simulix Evolution is a Flat Panel detector option to the Nucletron Simulix HP simulator system. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using a conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment. The Simulix Evolution option consists of a digital Flat Panel detector and a PC based simulator workstation. The Flat Panel detector option replaces the current Image Intensifiers. The Flat Panel is a Amorphous silicon, digital detector, with a square image area of 41 by 41 cm. The PC based simulator workstation is the current DTI workstation, but ported to a Windows platform. 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.