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MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, MR-CT VVA allows the quantification of T2* in MR images of the heart and the liver. Finally, MR-CT VVA can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by MR-CT VVA are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

MR-CT VVA (MR-CT Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantification of MR and CT images of blood vessels, of the heart and MR images of the liver and cerebral spinal fluid. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen and can be exported in various electronic formats. MR-CT VVA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment. MR-CT VVA has a modular structure that consists of its previously cleared predicate devices: MRI-MASS, CT-MASS, MRI-FLOW, CMS-VIEW and MRA-CMS. MR-CT VVA comprises their respective functionalities for analyzing the blood vessels and the heart. In addition, MR-CT VVA includes new functionality for the 3D review of MR volumetric data.

X-RAY VVA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. X-RAY VVA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports. The analysis results obtained with X-RAY VVA are intended for use by cardiologists and radiologists: to support clinical decisions concerning the heart and vessels to support the evaluation of interventions or drug therapy applied for conditions of the heart . and vessels. X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by X-RA Y VVA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnoiss of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, intefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

X-RAY VVA (Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. X-RAY VVA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment. X-RAY VVA has a modular structure that consists of its previously cleared predicate devices: OCA-CMS, QVA-CMS, QLV-CMS, and CMS-VIEW. X-RAY VVA comprises their respective functionalities for analyzing the blood vessels and the left ventricle. In addition, X-RAY VVA includes new functionality for the analysis of: the right ventricle, stent and sub-segments, coronary anewysms, and bifurcations.

QPlaque MR is a post-processing software application that is intended to assist trained cardiologists and radiologists in the assessment of atherosclerosis. The software is intended in particular to aid in assessing vessel wall thickness and remodeling in the carotid arteries I OPlaque MR post-processes multi-spectral MR images to semi-automatically determine the boundaries of the lumen and outer vessel wall, and provides editing tools for manual drawing of plaque components. The software enables area and volume measurements of the vessel wall as well as quantification of user-indicated areas. QPlaque MR results can be used to support the decision-making process in clinical practice and to support conclusions in clinical trials.

QPlaque MR is able to read DICOM MR images from all major MR vendors. Vessel analysis data, generated by semi-automatic segmentation, detected stenosis and quantitative results can be saved in separate files enabling the comparison of results from different users. Radiologists, cardiologists and technicians use the QPlaque MR analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of MR data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment. In clinical practice QPlaque MR is used on workstations in review rooms or integrated in a PACS environment.

QAngio CT software solution has been developed for the objective and reproducible analysis of vessels in CTA images. It enables the quantitative analysis of CT angiograms based on automated segmentation. More specifically, QAngio CT can be used to quantify a number of lesion characteristics. QAngio CT is intended for use as an auxiliary tool in assessing CTA studies in clinical practice and in clinical trials. The analysis results obtained with QAngio CT are to be interpreted by cardiologists and radiologists.

QAngio CT is able to read DICOM CT images from all major CT scanner vendors. Vessel analysis data, generated by automated (and/or manual) segmentation, detected stenosis, and quantitative results, can be saved in separate files enabling the comparison of results from different users. Radiologists, cardiologists and technicians use the QAngio CT analytical software package to obtain objective and reproducible results. The obtained results may be used to support the interpretation of CTA data, or they are used in the evaluation of follow-up studies and the effectiveness of treatment. In clinical practice the QAngio CT software is used on workstations in review rooms or integrated in a PACS environment.

The QBrain software has been developed for the objective and reproducible analysis of MR images of the brain. It performs quantitative analysis of MR brain images based on automatic segmentation. More specifically, it quantifies the volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white matter hyperintensities (lesions). These parameters should only be used by trained medical professionals in clinical practice and to reach conclusions in clinical trials.

The QBrain software has been developped for the onalyses on MR brain images of based on automatic segmentation. More specifically, it quantifies the volumes of based on automatic segmentation: more openiture, more openiture (CSF), and white matter hyperintensities (lesions).

RSA-CMS has been developed for the objective and reproducible analysis on digital roentgen images (DICOM CR or DX) or digitised images in a PACS environment. Orthopedic specialist and core labs use the RSA-CMS standalone analytical software package in image post-processing for the evaluation of new implant designs, coatings and new cementation techniques in clinical trials. When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials.

RSA-CMS is a software package that "automatically" performs Roentgen Stereophotogrammetric Analysis (RSA) in digital images. This software package runs on a PC with the Windows 2000 or XP operating system.

Ortho-CMS is an orthopaedic analysis software tool. It has been developed to optimize preoperative planning through digital prosthesis templating and to enable preoperative and postoperative measurements in digital or digitized X-Ray images. Ortho-CMS software is meant solely for use by trained medical personnel. The intended purposes of Ortho-CMS are: - Displaying of X-Ray images - Supporting planning of joint replacement operations - Supporting clinical diagnoses on implant loosening - Enabling preoperative and postoperative measurements for clinical and research purposes

In orthopaedics, radiographs are used to diagnose and analyse various kinds of orthopaedic disorders, generative joint conditions, and bone fractures, and to evaluate orthopaedic treatments such as osteotomies and total joint arthroplasty. These arthroplasties need to be evaluated in order to assess the quality of the procedure. Measurements on radiographs of endoprostheses include the assessment of radiolucent lines around the prosthesis, bone growth or bone resorption, position of the prosthesis, motion of the prosthesis relative to the surrounding bone, and the determination of wear of the polyethylene components. Since the measurements on radiographs are commonly performed manually, considerable intra-observer and inter-observer variation exists. Automation of the measurements might increase the objectivity and speed of the analysis, and decrease the variation of the results. In radiology, digital roentgen imaging techniques are increasingly being used over plain film radiographs. The digital roentgen images (DICOM CR or DX) are easily accessible from a medical picture archive (PACS) through a network connection. Ortho-CMS supports the radiologist by facilitating the diagnosis of orthopaedic digital images and allows the orthopaedic specialist to perform a pre-surgical planning and a post-surgical evaluation on these images. Further, Ortho-CMS can be deployed as a measurement tool for core-labs that focus on quality assessment of orthopaedic implants or it can be used by bone centres that need to make measurements in donor bone images for joints replacement purposes.

MRA-CMS has been developed for the objective and reproducible analysis of vessels from MRA data sets. The MRA software parameters may be used to semi-automatically determine lumen length, cross sectional parameters and percent stenosis. When interpreted by a trained physician these parameters may be useful in supporting the determination of clinical diagnoses and subsequent clinical decision making processes.

MRA-CMS can be utilized to determine lumen lengths; minimum and maximum cross sectional diameters and percent stenosis. MRA-CMS improves productivity of the clinician by semi-automating the measurement function for routine vascular measurements.

CT-MASS has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets. The CT-MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, BSV, stroke volume, ejection factor, peak ejection and filling rates, myocardial mass, regional wall thickness, as well as well as wall thickening/thinning, and regional wall motion. This is including the axial to short axis reformat. When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.

CT-MASS is a professional state-of-the-art analytical software tool designed for UNIX, Linux as well as Windows platforms. CT-MASS facilitates the import and visualization of multi-slice, multi-phase CT data sets encompassing the cardiac chambers via CD-Rom and digital network. This CT-MASS functionality is independent of the CT equipment vendor. CT-MASS provides objective and reproducible global and regional two-, three- and four-dimensional clinically relevant parameters describing left and right ventricular heart function, such as ventricular volumes, regional wall thickness and wall thickening/thinning CT-MASS is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the noninvasive assessment of heart function.

QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians. i.e. cardiologists. radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.

QVA-CMS is a state-of-the-art analytical software tool designed for Windows operating systems. QVA-CMS analytical software facilitates the import and visualization of X-ray images via CD-ROM and digital network. The QVA-CMS functionality is independent of the X-ray acquisition equipment vendor. QVA-CMS, performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions in selected regions of interest. The analysis results of user's selection can be reported in user-defined configuration, exported in general formats and transported for storage via communication with standard Microsoft office packages.