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CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use: - Calculate the dimensions of cardiovascular structures; - Quantify stenosis in coronary vessels; - Determine C-arm position for optimal imaging of cardiovascular structures; - Quantify pressure drop in coronary vessels; - Enhance stent visualization and measure stent dimensions; CAAS Workstation is intended to be used by or under supervision of a cardiologist.

CAAS Workstation is an image post-processing software package for advanced visualization and ysis in the field of cardiology or radiology and offers functionality to view X-Ray angiographic images, to segment cardiovascular structures in these images, to analyze and quantify these cardiovascular structures and to present the results in different formats. CAAS Workstation is a client-server solution intended for usage in a network environment or standalone usage and runs on a PC with a Windows operating system. It can read DICOM X-ray images from a directory, or receive DICOM images from the X-ray or PACS system. CAAS Workstation is composed out of the following analysis workflows: StentEnhancer and vFFR for calculating dimensions of coronary vessels, quantification of stenosis and calculating the pressure drop and vFFR value based on two 2D X-Ray angiographic images. Semi-automatic contour detection forms the basis for the analyses. Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.

Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostic in the field of cardiology by means of segmentation of cardiovascular structures and enabling the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images as well as measurement and reporting tools by providing the following functionality: - Segmentation of cardiovascular structures and calculation of quantitative results ● - Support signal intensity analysis for the myocardium - . Quantification of MR parametric maps (such as T1, T2, T2* relaxation) - Visualization and quantification of blood flow velocity and directions When the results provided by CAAS MR Solutions are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS MR Solutions is an image post-processing software package which offers functionality to import DICOM MR images, to segment cardiovascular structures in these images, to visualize and evaluate blood flow in cardiovascular structures, to analyze and quantify these cardiovascular structures and to present the analysis results in different formats. CAAS MR Solutions is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM MR images from an accessible file system, hard disk (local directory), or (indirectly) received from the MR or PACS system. CAAS MR Solutions provides the functionality to import the DICOM MR images and to organize the loaded DICOM MR images into patients, studies, and series. CAAS MR Solutions comprises functionalities for viewing and quantification of cardiovascular MR images, segmentation of cardiovascular structures and calculation of quantitative results, for signal intensity analysis of the myocardium, for quantification of MR parametric maps and for visualization of blood flow velocity and directions. Results can be displayed on the screen, printed, or saved in a variety of formats to hard disk, network or PACS system. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.

Standalone software for medical intended for advanced visualization and quantitative analysis in adult populations to support physicians with diagnostics by means of enabling segmentation, quantification, review, and reporting of cardiac structures based on multi-dimensional echocardiographic images. Caas Qardia facilitates the following use: · Segmentation of cardiovascular structures · Calculation of quantitative indices describing cardiovascular function and structure When the results provided by Caas Qardia are used in a clinical decision making, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

Caas Qardia is an image post-processing software package for diagraphy, which offers functionality to view echocardiographic images, to segment cardiovascular structures in these images, to analyze and quantify these cardiovascular structures and to present the analysis results in different formats. Caas Qardia is a web-based solution for diagnostic echocardiography, intended for usage in a network environment or standalone usage. Caas Qardia is composed of the following key analysis features: - -Study selection (from PACS server or local data) - -Image viewing - -Left ventricular ejection fraction analysis - -Left ventricular strain analysis - -Cardiac geometric measurements and velocity measurements - -Reporting - -Export of results Results can be displayed on the screen, printed, or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.

CAAS MR Solutions is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading and interpreting cardiovascular MR images and to visualize and evaluate blood flow in cardiovascular structures to support clinical decision making. CAAS MR Solutions features segmentation of cardiovascular structures, enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images as well as measurement and reporting tools by providing the following functionality: - Segmentation of cardiovascular structures and calculation of quantitative results - Support signal intensity analysis for the myocardium ● - Quantification of MR parametric maps (such as T1, T2, T2* relaxation) - Visualization and quantification of blood flow velocity and directions When the results provided by CAAS MR Solutions are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS MR Solutions is an image post-processing software package which offers functionality to import DICOM MR images, to segment cardiovascular structures in these images, to visualize and evaluate blood flow in cardiovascular structures, to analyze and quantify these cardiovascular structures and to present the analysis results in different formats. CAAS MR Solutions is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM MR images from an accessible file system, hard disk (local directory), or (indirectly) received from the MR or PACS system. CAAS MR Solutions provides the functionality to import the DICOM MR images and to organize the found DICOM MR images into patients, studies and series. CAAS MR Solutions is composed out of analysis workflows of its previously cleared devices: CAAS MRV, CAAS MR Flow and CAAS MR 4D Flow. CAAS MR Solutions comprises their respective functionalities for viewing and quantification of cardiovascular MR images. In addition, CAAS MR Solutions offers new functionality for signal intensity analysis of the myocardium and for MR parametric maps for T1 relaxation. The CAAS MR Solutions product has a moderate level of concern. Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.

CAAS MR 4D Flow is a software product intended to be used by or under supervision of a cardiologist or radiologist in order to visualize and evaluate blood flow in cardiovascular structures based on multi-slice, multi-phase and velocity encoded MR images to support clinical decision making. CAAS MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality: Segmentation of cardiovascular structures; Visualization of blood flow velocity and directions; Calculation of quantitative cardiovascular results. When the results provided by CAAS MR 4D Flow are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS MR 4D Flow offers functionality to import images; to analyze the behavior of blood flow in vessels and through heart valves in phase-contrast MR (Flow) images semi-automaticative flow analysis on the images, and to present the analysis results in different formats. The CAAS MR 4D Flow software is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM MR Images from an accessible file system (CD) and CAAS MR 4D Flow provides the functionality to scan the contents of a specific directory and to organize the found DICOM MR images into patients, studies and logical imagesets. A phase-contrast MR imageset is necessary for performing 4D Flow analysis. Depending on the specific analysis goals, one or more MR imagesets may be added for reference purposes (phase contrast or cine imagesets). After the MR images are read, the CAAS MR 4D Flow software provides functionality to perform the following measurements: - . Extraction (and, if wanted, manual editing) of a 3D mesh of the vessel lumen, based on user input points. - Visualization of color-coded 3D blood motion vectors originating from one or more user-defined planes in the cardiovascular structure. - Visualization of color-coded (fixed) streamlines and (animated) pathlines indicating blood movement pattern originating from one or more user-defined planes in the cardiovascular structure. - Visualization and quantification of blood flow through a pre-defined plane. Methods to automatically correct for image artifacts or user errors like aliasing, eddy-currents, movement offset, or incorrect velocity direction indication, are available. The results of the analysis will be generated as visual snapshots or animation of 3D blood motion (see above) or quantifications, for example: - Flow through a plane over time (forward, backward, total) - Min, max, mean, average, sdev velocity through a plane over time - Pulse wave velocity over a segment of the vessel Results can be displayed in numerical format or (if applicable) as graphs. An analysis can be saved to hard disk to enable re-analysis of the data. Visual results can be exported as animation or bitmap images. A graphic report can be exported in DICOM or PDF format, containing both numerical and also be printed. Numerical results can be exported as text files.

3mensio Workstation enables visualization and measurement of the heart and vessels for: - · Pre-operational planning and sizing for cardiovascular interventions and surgery - · Postoperative evaluation - · Support of clinical diagnosis by quantifying dimensions in coronary arteries - · Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: - · Segmentation of cardiovascular structures - · Automatic and manual centerline detection - · Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched - CMPR, Slabbing, MIP, AIP, MinIP - · Measurement and annotation tools - Reporting tools

The 3mensio Workstation software allows cardiologists, radiologist and clinical specialists to select patient studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks. 3mensio Workstation can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting ultrasound and X-ray Angio data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. 3mensio Workstation contains two modules, 3mensio Structural Heart (containing submodule cCTA), and 3mensio Vascular which can be marketed in combination or as separate solutions: 3mensio Structural Heart enables assessment and measurement of differen structures of the heart, e.g. aortic valve, mitral valve and ventricles. It provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures. 3mensio cCTA enables assessment and measurement of the coronary arteries and can help in the quantification of the dimensions of the coronary arteries and of the calcified plaques present in coronary arteries. 3mensio Vascular enables assessment of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures. The results can be displayed, printed or saved in a variety of formats to a hard disk, network, PACS system or CD. Results can also be printed as a hardcopy.

CAAS Workstation is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading, co-registering and interpreting cardiovascular X-Ray images to support diagnoses and for assistance during intervention of cardiovascular conditions. CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use: - Calculate the dimensions of cardiovascular structures; - Quantify stenosis in coronary and peripheral vessels; - Quantify the motion of the left and right ventricular wall; - Perform density measurements; - Determine C-arm position for optimal imaging of cardiovascular structures; - Enhance stent visualization and measure stent dimensions; - Co-registration of angiographic X-Ray images with IVUS and OCT images. CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist. When the results provided by CAAS Workstation are used in a clinical setting to support diagnoses and for assistance during intervention of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS Workstation is designed as a stand-alone modular software product for viewing and quantification of X-ray angiographic images intended to run on a PC with a Windows operating system. CAAS Workstation contains the analysis modules QCA, QCA3D, QVA, LVA, RVA and StentEnhancer of the previously cleared predicate device CAAS Workstation (K133993) for calculating dimensions of coronary and peripheral vessels and the left and right ventricles, quantification of stenosis, performing density measurements, determination of optimal C-arm position for imaging of vessel segments and functionality to enhance the visualization of a stent and to measure stent dimension. Semi-automatic contour detection forms the basis for the analyses. Functionality to co-register X-ray angiographic images and intravascular imaging techniques (such as intravascular ultrasound and optical coherence tomography) is added by means of the analysis module IV-LINQ. With co-registration a common frame of intravascular imaging techniques with X-ray angiographic images is provided using a three-dimensional model. This functionality is based on the Volcano Angio-IVUS Mapping system (K060483). In the IV LINQ workflow the user has to select two angiographic X-ray images in DICOM format. The user indicates a catheter path starting at the imaging tip. This path can be optimized manually by adding, deleting or moving control point on the drawn path. After the catheter path is drawn in both angiographic X-ray images, a 3D reconstruction of the catheter path is calculated. The user then has to select one IVUS or OCT dataset in DICOM format or the data is streamed from the intravascular imaging console with a DVI streamer. The IVUS or OCT pullback must be acquired using a motorized pullback device. After the 3D catheter path from X-ray angiographic images is calculated and the IVUS or OCT pullback is loaded, IV-LINQ co-registers each IVUS or OCT frame with a position on the 3D catheter path using a distance mapping algorithm. On intravascular images diameter and area measurements can be performed. The quantitative results of CAAS Workstation support diagnosis and intervention of cardiovascular conditions. The analysis results are available on screen, and can be exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.

CAAS A-Valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root. Based on angiographic X-ray images an analysis is performed: To assist in C-arm projection selection to optimize visualization during treatment; To calculate dimensions of the aortic root corrected for out-of-plane magnification and foreshortening errors; To provide an objective and reproducible grading method for aortic regurgitation based on time versus density curves extracted from an aortogram. The software is used by or under supervision of a cardiologist. When the results provided by CAAS A-Valve are used in a clinical setting to support diagnoses or for assistance during intervention of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS A-Valve is a stand-alone software application, intended to run on a PC with a Windows operating system. The images for analysis can be read from a directory or from an X-ray system or PACS through a command line interface. The results can be displayed on the screen, printed or saved in a variety of formats to a hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy. CAAS A-Valve consists of two separate workflows, Optimal Projection and qRA (quantitative Regurgitation Analysis). With CAAS A-Valve - Optimal Projection, angiographic images of the aortic root can be analyzed to determine a good projection for visualization of the aortic root and to perform basic measurements. As input for analysis, two angiographic images of the aortic root can be selected. On both images the contour of the aortic root is defined manually by the user. The 2D aortic root contours in each image are used to generate a 3D reconstruction of the aortic root. By indicating the right coronary cusp in both projections the software determines the recommended projection (PRL projection). This projection can be used to acquire an aortogram with the cusps in a line and all cusps visible. Additionally it is possible to perform diameter and length measurements based on the 3D reconstruction. The Optimal Projection workflow is 510(k) cleared under K113076. CAAS A-Valve - qRA is used to determine aortic regurgitation (also referred to as aortic insufficiency). This is done based on a multi-frame image showing the aortic root and the left ventricle while contrast liquid is injected in the aorta during the X-ray acquisition; also known as an aortogram. The user draws the contour of the aortic root and the left ventricle and indicates the basal plane. Next a static background, which is obtained from the images before contrast injection, is subtracted resulting in an image sequence in which the intensities correlate to the amount of contrast liquid. Based on this image sequence combined with the user input, time versus contrast density curves are calculated and visualized for both the aortic root and the left ventricle. The ratio between the area under the curve of the aortic root and the area under the curve of the left ventricle represents the amount of contrast liquid flowing from the aortic root to the left ventricle and is a measure for regurgitation. Additionally a dynamic color map is shown for the left ventricle. This color map is achieved by showing the accumulative area under the curve at each image frame as a movie with the same frame rate as used during the acquisition of the multi-frame image. CAAS A-Valve is designed for use in clinical practice to support the physician during or in preparation of treatment of the aortic root.

Based on Intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) images CAAS IntraVascular enables quantification of artery and/or stent dimensions.

CAAS IntraVascular is a stand-alone software application intended to run on a PC with a Windows operating system. CAAS IntraVascular is designed for viewing and analyzing DICOM data from intravascular ultrasound (IVUS) and optical coherence tomography (OCT) studies. CAAS Intravascular provides (semi-)automatic detection of vessel and stent structures and quantitative analysis of the dimensions of these structures. CAAS IntraVascular is designed for use in clinical practice to support the physician to diagnose the patient.

3mensio Workstation is a software solution that is intended to provide Cardiologists. Radiologists and Clinical Specialists additional information to aid them in reading and interpreting DICOM compliant medical images of structures of the heart and vessels. 3mensio Structural Heart enables the user to: - Visualize and measure (diameters, lengths, areas, volumes, angles) structures . of the heart and vessels - Quantify calcium (volume, density) . 3mensio Vascular enables the user to: - Visualize and assess stenosis, aneurisms and vascular structures . - Measure the dimensions of vessels (diameters, lengths, areas, volumes, . angles) 3mensio Workstation enables visualization and measurement of structures of the heart and vessels for: - Pre-operational planning and sizing for cardiovascular interventions and . surgery - Postoperative evaluation . To facilitate the above, the 3mensio Workstation provides general functionality such as: - . Segmentation of cardiovascular structures - Automatic and manual centerline detection . - Visualization and image reconstruction techniques: 2D review, Volume . - Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinIP - . Measurement and annotation tools - Reporting tools .

3mensio Workstation is a stand-alone software application intended to run on a PC with a Windows operating system. It allows Cardiologists, Radiologists and Clinical Specialists to select patient studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. The 3mensio Workstation contains two modules, 3mensio Structural Heart and 3mensio Vascular, which can be marketed in combination or as separate solutions. 3mensio Structural Heart enables assessment and measurement of different structures of the Heart, e.g. aortic valve, mitral valve, ventricles. It provides simple techniques to assess the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures. 3mensio Vascular enables assessment of vessels and can help the physician identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular surgery. The 3mensio Workstation can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting ultrasound and X-ray Angio data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks.