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Indications for use of TomTec-Arena software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.

TomTec-Arena™ is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different TomTec Image-Arena™ platforms and TomTec-Arena Server®, their derivatives or third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. TomTec-Arena™ TTA2 consists of the following optional modules: - Image-Com - 4D LV-Analysis and 4D LV-Function - 4D RV-Function - 4D Cardio-View - 4D MV-Assessment - Echo-Com - 2D Cardiac-Performance Analysis - 2D Cardiac-Performance Analysis MR - 4D Sono-Scan - Reporting - Worksheet - TomTec-Arena Client

Indications for use of TomTec-Arena software are diagnostic review, quantification and reporting of cardiovascular, fetal and abdominal structures and function of patients with suspected disease.

TomTec-Arena is a clinical software package for reviewing, quantifying and reporting digital medical data. TomTec-Arena runs on high performance PC platforms based on Microsoft Windows operating system standards. The software is compatible with different TomTec Image-Arena™ platforms, their derivatives or third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. Tom Tec-Arena consists of the following optional clinical application packages: Image-Com, 4D LV-Analysis/Function, 4D RV-Function, 4D Cardio-View, 4D MV-Assessment, Echo-Com, 2D Cardiac-Performance Analysis, 2D Cardiac-Performance Analysis MR, 4D Sono-Scan.

The clinical application package 2D Cardiac Performance Analysis MR is indicated for cardiac quantification based on digital magnetic resonance images. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagnosis purposes of patients with suspected heart disease.

2D Cardiac Performance Analysis MR (=2D CPA MR) is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 2D CPA MR is a software for the analysis, storage and retrieval of digitized magnetic resonance (MR) images. The data can be acquired by cardiac MR machines. The digital 2D data can be used for comprehensive functional assessment of the myocardial function. 2D CPA MR is designed to run with a TomTec Data Management Platform (Image-Arena™, their derivatives or any other platform that provides and supports the Generic CAP Interface. The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data. The TomTec Data Management Platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities. 2D CPA MR is designed for the 2-dimensional functional analysis of myocardial deformation. Based on two dimensional datasets a feature tracking algorithm supports the calculation of a 2D contour model that represents the endocardial and epicardial border. From these contours the corresponding velocities, displacement and strain can be derived.

4D LV-Analysis is intended to retrieve, analyze, and store digital ultrasound images for computerized dynamic 3-dimensional image analysis. 4D LV-Analysis reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for analysis. It is intended as a digital 4D ultrasound image processing tool for cardiology. 4D LV-Analysis 3.0 is intended as software for analysis of the left ventricle in heart failure patients.

The 4D LV-Analysis® 3.0 software is a clinical application package for high performance PC platforms based on Microsoft Windows operating system standards. 4D LV-Analysis is software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images. 4D LV-Analysis is compatible with different TomTec Image-Arena™ platforms, their derivatives or any other platform that provides and supports the Generic CAP Interface. Platforms enhance the workflow by providing the database, import, export and other functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes. 4D LV-Analysis is designed for 2- and 3-dimensional morphological and functional analyses of the left ventricle. Based on three dimensional datasets a semi-automatic 3D surface model finding algorithm supports the calculation of a 4D model that represents the cavity of the LV. From that model, global as well as regional volumetric changes can be derived. By looking at the timing of regional contractions, dyssynchrony of a ventricle can be quantified and visualized. For visualization, parametric maps are used that indicate areas with a delayed contraction. Thus 4D LV-Analysis improves the functional analysis of the LV and presentation of findings to cardiologists and electro-physiologists and visualizes the contraction pattern of the LV to assess dyssynchrony.

The Image-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities. Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform. The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool. Image-Arena is not intended to be used for reading of mammography images. Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools. . Echo-Com software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Com software is intended for reviewing, wall motion scoring and reporting of stress echo studies.

Image-Arena is an SQL database based image management system that provides the capability to import, export, store, retrieve and report digital studies. lmage Arena is developed as a common interface platform for TomTec - and commercially available analysis and quantification tools (= clinical application packages) that can be connected to Image-Arena through the Generic Clinical Application Package interface (= Generic CAP Interface) lmage-Arena manages different digital medical data from different modalities except digital mammography. Image-Arena is suited as stand-alone workstation as well as networked multisystem server / client installations. Image-Arena runs on an integrated Intel Pentium high performance computer system based on Microsoft™ Windows standards. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols. Image-Arena provides the possibility to create user defined medical reports. The system does not produce any original medical images. Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena platform or can be integrated into Third Party platforms, such as PACS or CVIS. Echo-Com is a clinical application package software for reviewing and reporting of digital stress echo data. Echo-Com is either embedded in Image-Arena Platform or can be integrated into Third Party platforms, such as PACS or CVIS.

4D Sono-Scan 1.0 is intended to analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. The 4D Sono-Scan 1.0 reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for subsequent 3D/4D tomographic reconstruction and rendering. It is intended as a general purpose digital 3D/4D ultrasound image processing tool. 4D Sono-Scan 1.0 intended as software for reviewing 3D/4D data sets and perform basic measurements in 3D.

The 4D Sono-Scan 1.0 is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 4D Sono-Scan 1.0 is proprietary software for the analysis, storage, retrieval, reconstruction and rendering of digitized ultrasound B-mode images. The data can be acquired by ultrasound machines that are able to acquire and store 4D datasets (i.e. Toshiba Aplio XG or Zonare Z.ONE). The digital 3D/4D data can be used for basic measurements like areas, distances and volumes. 4D Sono-Scan 1.0 is compatible to different TomTec Image-Arena platforms and their derivatives (i.e. Zonare IQ Workstation) for offline analysis. The platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes via the Generic CAP Interface. The Generic CAP (= clinical application packages) Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.

4D MV Assessment is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. 4D MV Assessment reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for subsequent 3D/4D tomographic reconstruction and rendering. It is intended as a general purpose digital 3D/4D ultrasound image processing tool for cardiology. 4D MV-Assessment 2.0 is intended as software to analyze pathologies related to the mitral valve.

4D MV-Assessment® is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 4D MV-Assessment is software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images and Color Doppler images. The data is acquired by ultrasound machines that are able to store compatible 3D/4D datasets. The digital 3D/4D data can be used for comprehensive morphological and functional assessment of the mitral valve. 4D MV-Assessment is compatible with different Tom Tec Image-ArenaTM platforms, their derivatives or any other platform that provides and supports the Generic CAP Interface. Platforms enhance the workflow by providing the database, import, export and other functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes. 4D MV-Assessment is designed for 2-, 3- and 4-dimensional morphological and functional analysis of mitral valves (MV). Based on an easy and intuitive workflow the application package generates models of anatomical structures such as MV annulus, leaflet and the closure line. Automatically derived parameters allow quantification of pre- and post-operative valvular function and comparison of morphology. 4D MV-Assessment improves the presentation of anatomy and findings to surgeons and cardiologists and visualizes the complex morphology and dynamics of the mitral valve. The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.

The Image-Arena Platform Software is intended to serve as a data management platform for clinical application packages. It provides information that is used for clinical diagnosis purposes. The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology. As the Image-Arena Applications software tool package is modular structured, clinical applications packages with different indications for use can be connected. Echo-Com software is intended to serve as a versatile solution for Stress Echo examinations in patients who may not be receiving enough blood or oxygen because of blocked arteries. Image-Com software is intended for reviewing, measuring and reporting of DICOM data of the cardiac modalities US and XA. It can be driven by Image-Arena or other third party platforms and is intended to launch other clinical applications. The clinical application package 2D Cardiac Performance Analysis is indicated for cardiac quantification based on echocardiographic data. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagnosis purposes of patients with suspected heart disease.

The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Vista™ Operating System standards. Image-Arena is suited as stand-alone workstation as well as networked multisystem installations. Image Arena is developed as a common interface platform for TomTec and 3rd party clinical application packages that can be connected to Image-Arena through the 300 party Interface. The different application packages have all access to the central database and can be enabled on a modular basis thus allowing custom tailored solutions of Image-Arena. The Image-Arena Application is a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions and X-ray angiography studies. The Image-Arena Application software tools are modular structured and consist of different software modules. The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician. The Image-Arena Application offers features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-,TomTec-file formats) in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used. Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data including 2D. M-Mode. Pulsed (PW) Doppler Mode, Continuous (CW) wave Doppler Mode, Power Amplitude Doppler Mode, Color Doppler Mode, Doppler Tissue Imaging and 3D/4D imaging modes. 2D Cardiac Performance Analysis 1.0 is an additional clinical application package for high performance PC platforms based on Microsoft Windows™ operating system standards. 2D Cardiac Performance Analysis 1.0 is a software for the analysis, storage and retrieval of digitized ultrasound B-mode images. The data can be acquired by ultrasound machines that are able to acquire and store 2D ultrasound datasets. The digital 2D data can be used for comprehensive functional assessment of the myocardial function. 2D Cardiac Performance Analysis 1.0 is designed to run with a TomTec Data Management Platform for offline analysis. The TomTec Data Management Platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes. 2D Cardiac Performance Analysis 1.0 is designed for the 2-dimensional functional analysis of myocardial function. Based on two dimensional datasets a speckle tracking algorithm supports the calculation of a 2D contour model that represents the endocardial and epicardial border. From that contours the corresponding velocities, displacement and strain can be derived. The 2D Cardiac Performance Analysis 1.0 application is a visual and quantitative method for assessing cardiac mechanics and the dynamics of cardiac motion.

The Image-Arena Platform Software is intended to serve as a data management platform for clinical application packages. It provides information that is used for clinical diagnosis purposes. The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology. As the Image-Arena Applications software tool package is modular structured. clinical applications packages with different indications for use can be connected. Echo-Com software is intended to serve as a versatile solution for Stress Echo examinations in patients who may not be receiving enough blood or oxygen because of blocked arteries Image-Com software is intended for reviewing, measuring and reporting of DICOM data of the cardiac modalities US and XA. It can be driven by Image-Arena or other third party platforms and is intended to launch other clinical applications.

The Image-Arena Application is a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions and Xray angiography studies. The Image-Arena Application software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product line Image-Arena Applications and Research-Arena Applications ( K071232) and Xcelera (K061995). The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician. The Image-Arena Application offers features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-, TomTec- file formats) in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used. Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data including 2D, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) wave Doppler Mode, Power Amplitude Doppler Mode, Color Doppler Mode, Doppler Tissue Imaging and 3D/4D imaging modes.

The Image-Arena VA Platform software is intended to serve as a data management platform for clinical application packages. As the Image-Arena Applications software tool package is modular structured, the clinical application packages are indicated as software packages for the ventricular analysis of the heart.

The Image-Arena Applications are a software tool package designed for analysis. documentation and archiving of ultrasound and magnetic resonance studies in multiple dimensions. The Image-Arena Applications software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product line Image-Arena Applications and Research-Arena Applications. The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician. The Image-Arena Applications offer features to import different digital 2D. 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-, TomTec- file formats) in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used. Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data.