DEVICE: Autoplaque for ORS Visual (B332VIAP0100)

Device Description: Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcified plaque lesions in coronary arteries from contrasted coronary CT angiographic studies for the evaluation of cardiovascular disease. Users can automatically segment the section of the coronary artery of interest, or manually input the centerline, to initiate a detailed and robust plaque lesion analysis routine. Analysis by Autoplaque provides biometric information that includes calcified plaque volume, non-calcified plaque volume with possible separation into low and high density non-calcified plaques, stenosis percentage, remodeling index, plaque length measurement, and proximal, distal, and stenosis diameters. If the Autoplaque add-on is used to analyze more than one coronary artery section, the additional parameters of total non-calcified plaque volume, total low density plaque volume, total calcified plaque volume, maximum remodeling index, maximum stenosis percentage, and the maximum plaque length will also be available. ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware.