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CaRi-Plaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CaRi-Plaque is a web-based image processing application. It is a non-invasive diagnostic reading software intended for use as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. CaRi-Plaque is intended for use by internal operators who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology may be present that is near or smaller than the scanning resolution. The analysis results produced by the software and provided to the Healthcare Professional are not intended to replace the skill and judgment of a qualified medical practitioner. The analysis results should be reviewed with other clinical information which may include but is not limited to: The patient's original CT images, clinical history, symptoms, clinical risk factors, results of other diagnostic tests, and the clinical judgement of appropriately qualified Healthcare Professionals.

CaRi-Plaque v1.0 ("CaRi-Plaque," the subject device) is a web-based software-only application for the quantitative and qualitative clinical analysis of previously acquired CCTA DICOM data for the purpose of characterizing and quantifying plaque formation and stenosis in coronary arteries. CaRi-Plaque aids healthcare professionals trained in cardiovascular health and patient care (including but not limited to Cardiologists, Radiologists and others) by describing the physical characteristics of coronary plaque volume and cross- sectional area, determined using a combination of 3D image thresholding computerized algorithms and manual editing tools to provide automated quantification and characterization of coronary atherosclerotic plaque and stenosis. The processing of CT scan data is performed by trained operators and the resulting CaRi-Plaque Report is provided to the healthcare professional to enable them to assess the extent and severity of coronary disease. The CaRi-Plaque report includes visual representations of each vessel and associated quantitative outputs. These quantitative outputs include: Plaque Burden, Calcified Plaque (CP) Volume, Total Plaque Volume, Noncalcified Plaque (NCP) Volume, Low Density Noncalcified Plaque (LD-NCP) Volume, Remodeling Index, and Maximum Stenosis. CaRi-Plaque does not replace standard clinical practice or clinical decisionmaking, and the results of the CaRi-Plaque analysis are to be used in the context of other patient information by the healthcare professional. The healthcare professional may request a re-analysis of the CT scan data if they do not agree with the report analysis.

CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images. CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis. CariCloud analysis results are indicated for use for all patients referred for CCTA imaging.

CariCloud is an image processing prescription software device intended to be used to display, manipulate and quantify previously acquired CT images. Datasets are downloaded from remote systems for clinical interpretation. Trained users will initiate and oversee image analysis and intervene when necessary to correct processing errors. The outcome of analysis will be used to create a summary report that includes qualitative and quantitative analysis.