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cvi42 is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. lt enables: · Importing cardiac MR & CT Images in DICOM format. • Supporting clinical diagnostics by qualitative analysis of cardiac MR & CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multiplanar reconstructions of the images. • Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR & CT images, specifically signal intensity, distance, area, volume, and mass. • Supporting clinical diagnostics by using area and volume for measuring cardiac function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR & CT images. • Flow quantifications based on velocity encoded cardiac MR images (including two and four dimensional flow analysis). • Strain analysis of cardiac MR images by providing measurements of 2D LV myocardial function (displacement, velocity, strain, strain rate, time to peak, and torsion). · Supporting clinical diagnostics of cardiac CT images including quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores, visualization and quantitative measurement of heart structures including coronaries, femoral, aortic, and mitral valves. · Evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplanar reconstruction (MPR), thin/thick maximum intensity projection (MIP), inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images. The software package is designed to support the physician in confirming the presence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. cvi42 shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for cvi42 and its manual workflows is not restricted; however, cvi42's semiautomated machine learning algorithms, included in the MR Function and CORE CT modules, are intended for an adult population. Further, image acquisition by a cardiac MR or CT scanner may limit the use of the software for certain sectors of the general public. cvi42 shall not be used to view or analyze images of any part of the body except the cardiac images acquired from a cardiovascular magnetic resonance or computed tomography scanner.

cvi42 Software Application ("cvi42") is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system. Combining digital image processing, visualization, quantification, and reporting tools, cvi42 is designed to support physicians in the evaluation and analysis of cardiovascular imaqing studies. cvi42 uses machine learning techniques to aid in semi-automatic contouring of regions of interest in cardiac MR or CT images. The data used to train these machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models. cvi42 has a graphical user interface which allows users to analyze cardiac MR & CT images qualitatively and quantitatively. cvi42 accepts uploaded data files previously acquired by MR or CT scanners or other data collection equipment but does not interface directly with such equipment. Its functionality is independent of the type of vender acquisition equipment. The analysis results are available onscreen and can be saved with the software for future review.

The Cardiac CT Function Software Application is indicated to be used with multi-phase, multi-slice cardiovascular CT angiography images to assist qualified medical professionals in assessing and evaluating cardiac function. CT Function includes manual and semi-automatic heart segmentation of 2 chambers (LV and RV) and calculation of cardiac function metrics including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and LV myocardial mass.

Circle's Cardiac CT Function Software Application ("CT Function Module" or "CT Function", for short) is a software device that enables the analysis of cardiac images acquired using computed tomography (CT) scanners. It is designed to support physicians in the visualization, and analysis of heart function through the calculation of parameters such as volume and mass. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The CT Function Module does not interface directly with any data collection equipment, and its functionality is dependent on the type of vendor acquisition equipment. The analysis results are available on-screen or can be saved for future review. CT Function consists of multiplanar reconstruction (MPR) views and 3D rendering of the original CT data. The module displays three MPR views that the user can freely adjust to any position and orientation. Lines and regions of interest (ROIs) can be manually drawn on these MPR images for quantitative measurements. The CT Function Module implements an Artificial Intelligence / Machine Learning (AI/ML) algorithm to detect and segment heart structures and post-processing methods to convert the heart segments to editable surfaces. All surfaces generated by the system are editable and users are advised to verify and correct any errors; if desired, users can also perform seqmentation of the cardiac structures manually using surface contour generation tools.

The Myocardial Strain Software Application is intended for qualitative and quantitative evaluation of cardiovascular magnetic resonance (CMR) images. It provides measurements of 2D LV myocardial function (displacement, velocity, strain rate, time to peak, and torsion); these measurements are used by qualified medical professionals, experienced in examining and evaluating CMR images, for the purpose of obtaining diagnostic information for patients with suspected heart disease as part of a comprehensive diagnostic decision-making process.

Circle's Myocardial Strain Software Application (Strain Module) is a software device that enables the analysis of CMR images acquired using SSFP cine imaging. It is designed to support physicians in the visualization, evaluation, and analysis of myocardial tissue deformation through CMR feature tracking. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The Strain Module can be integrated into an image viewing software intended for visualization of cardiac images, such as Circle's FDA-cleared cvi42 software. The Strain Module does not interface directly with any data collection equipment, and its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen or can be saved for future review. The Strain Module implements an algorithm for deformations modeling of topologies that relies on a two-dimensional (2D) version of the nearly incompressible deformable model. The deformation of the model is assumed to be completely determined by a set of control points placed on the middle curve of the myocardial wall; these points are first defined by the end-user in a reference phase, and then detected in all other phases based on the feature tracked boundaries and incompressibility constraint of the model. Once this feature tracking is complete, the Strain Module computes and reports various global and regional deformation quantities such as strains (including Global Longitudinal Strain (GLS) and Global Circumferential Strain (GCS)), strain rates, displacements, velocities, and torsion. These measurements of myocardial deformation can be made, as appropriate, in the radial, circumferential, or longitudinal directions.

TruPlan enables visualization and measurement of structures of the heart and vessels for: - · Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure - · Post-procedural evaluation for the LAAC procedure To facilitate the above, TruPlan provides general functionality such as: - · Segmentation of cardiovascular structures - · Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR - · Simulation of TEE views, ICE views, and fluoroscopic rendering - · Measurement and annotation tools - · Reporting tools TruPlan's intended patient population is comprised of adult patients.

The TruPlan Computed Tomography (CT) Imaging Software application ("TruPlan") is a software as a medical device that helps qualified users with image-based pre-procedural planning and post-procedural follow-up of the Left Atrial Appendage Closure (LAAC) procedure using CT data. TruPlan is designed to support the anatomical assessment of the Left Atrial Appendage (LAA) prior to and following the LAAC procedure. This includes the assessment of the LAA size, shape, and relationships with adjacent cardiac and extracardiac structures. This assessment helps the physician determine the size of a closure device needed for the LAAC procedure and evaluate LAAC device placement in a follow-up CT study. The TruPlan application is a visualization software and has basic measurement tools. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications physicians use for planning or follow-up for a LAAC procedure.

cvi42 Auto is intended to be used for viewing, post-processing, qualitative evaluation of cardiovasular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels: perform calcium scoring: and to confirm the presence of physician-identified lesion in blood vessels. The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population. cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive decision-making process.

cvi42 Auto is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system. Combining digital image processing, visualization, guantification, and reporting tools, cvi42 Auto device is designed to support the physician in confirming the presence or absence of physician-identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. cvi42 Auto uses machine learning techniques to aid in semi-automatic contouring of regions of interest of cardiac magnetic resonance (MR) or computed tomography (CT) images as follows: - 1. Cardiac Function: semi-automatic contouring of the four heart chambers (including left ventricle, left atrium, right ventricle, right atrium) in MR images. - 2. Calcium Assessment: using pixel intensity technique, identify calcified plaque in major coronary arteries in non-contrast enhanced CT images. - 3. Coronary Analysis: semi-automatic placement of centerline in coronary vessels to visualize the coronary arteries and assess stenosis in non-contrast enhanced CT images. The data used to train these machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models. cvi42 Auto software has a graphical user interface which allows users to analyze cardiac images qualitatively and quantitatively for volume/mass, function and signal intensity changes including a reporting function. The device can be integrated into a hospital, private practice environment, or medical research institution and provides clinical diagnosis decision support tools for the cardiovascular MR and CT technique. Additionally, the software is designed to generate 3D view of the heart in CT images for qualitative assessment of the coronary artery. No quantitative assessment can be made from the 3D image. The software does not interface directly with any data collection equipment; instead, the software uploads data files previously generated by such equipment. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on-screen and can be saved within the software for future review.

TruPlan enables visualization and measurement of structures of the heart and vessels for pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure. To facilitate the above, TruPlan provides general functionality such as: - Segmentation of cardiovascular structures - Visualization and image reconstruction techniques: 2D review, Volume Rendering. MPR - Simulation of TEE views, ICE views, and fluoroscopic rendering - Measurement and annotation tools - Reporting tools

The TruPlan Computed Tomography (CT) Imaging Software application (referred to herein as "TruPlan") is a software as a medical device (SAMD) that helps qualified users with imagebased pre-operative planning of Left Atrial Appendage Closure (LAAC) procedure using CT data. The TruPlan device is designed to support the anatomical assessment of the Left Atrial Appendage (LAA) prior to the LAAC procedure. This includes the assessment of the LAA size, shape, and relationships with adjacent cardiac and extracardiac structures. This assessment helps the physician determine the size of a closure device needed for the LAAC procedure. The TruPlan application is a visualization software and has basic measurement tools. The device is intended to be used as an aid to the existing standard of care. It is not replacing the existing software applications physicians use for planning the Left Atrial Appendage Closure procedure. Pre-existing CT images are uploaded in TruPlan application manually by the end-user. The images can be viewed by the user in the original CT image as well as simulated views. The software displays the views in a modular format as follows: - LAA - Fluoro (fluoroscopy, simulation) - Trans Esophageal Echo (TEE, simulation) - Intra Cardiac Echography (ICE, simulation) - Thrombus - Multiplanar Reconstruction (MPR) Each of these views offer the user visualization and quantification capabilities for pre-procedural planning of the Left Atrial Appendage Closure procedure; none are intended for diagnosis. The quantification tools are based on user-identified regions of interest and are user-modifiable. The device allows users to perform the measurements (all done on MPR viewers) listed in Table 1. Additionally, the device generates a 3D rendering of the heart (including left ventricle, left atrium, and LAA) using machine learning methodology. The 3D rendering is for visualization purposes only. No measurements or annotation can be done using this view. TruPlan also provides reporting functionality to capture screenshots and measurements and to store them as a PDF document. TruPlan is installed as a standalone software onto the user's Windows PC (desktop) or laptop (Windows is the only supported operating system). TruPlan does not operate on a server or cloud.

cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the cvi42 is not restricted, however the image acquisition by a cardiac CT or MR scanner may limit the use of the device for certain sectors of the general public.

cvi42 vascular add-on is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cvi42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT & MR images.

ct42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables; Importing Cardiac CT Images in DICOM format Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multi-planner reconstructions of the images. Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and mass Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac CT images. Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the ct42 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public. ct42 shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.

ct42 is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. ct42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT images for volume/mass, and calcium scoring. It provides a comprehensive set of tools for the analysis of Cardiovascular Computed Tomography (CT) images.

cmr42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: Importing Cardiac MR Images in DICOM format Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases. Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR images, specifically distance, area, volume and mass Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR images. Flow quantifications based on velocity encodes images It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the cmr42 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public. cmr42 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.

cmr42 is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cmr42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac images for volume/mass, and flow quantification. It provides a comprehensive set of tools for the analysis of Cardiovascular Magnetic Resonance (CMR) images.