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ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic or non-ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) for the calculation, quantification and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making. The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.

ADAS 3D is a stand-alone software tool intended to be used for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D software aids in the non-invasive calculation, quantification of cardiac imaging data to support a comprehensive diagnostic decision-making process for understanding cardiovascular disease. ADAS 3D exports information to multiple industry standard file formats suitable for documentation and information sharing purposes. The 3D data is exported into industry standard file formats supported by catheter navigation systems. ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support: - Visualization of the distribution of the enhancement in a three-dimensional (3D) chamber of the heart. - Quantification of the total volume of the enhancement within the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure. - . Calculation, quantification and visualization of corridors of intermediate, signal intensity enhancement in the LV. - Quantification and visualization of the total area and distribution of the enhancement within the left Atrium (LA). Additionally, ADAS 3D imports DICOM CTA images to support: - Quantification of LV wall thickness. - Identification and Visualization of other 3D anatomical structures. - Quantification and visualization of LA wall thickness. - Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures. Additionally, ADAS 3D imports DICOM Magnetic Resonance Angiography (MRA) images to support: - Identification and Visualization of other 3D anatomical structures. Additionally, ADAS 3D uses the following machine-learning-based features: - Standard Initialization of the LV, LA, and Aorta from CTA - Standard Initialization of the Coronary Arteries from CTA - Standard Initialization of the LA from CTA - Standard Initialization of the LV from 2D LGE-MRI and Automatic Slice Alignment ● - Standard Initialization of the LV from 3D LGE-MRI - Standard Initialization of the LA from 3D LGE-MRI

ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, radiologists, radiologists, radiologists or trained technicians) for the calculation and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making. The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arthythmias (e.g., ventricular tachycardia) or risk stratification has not been established.

ADAS 3D is a software tool intended to be used for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D is intended for the non-invasive calculation, quantification of cardiac imaging data to support a comprehensive diagnostic decision-making process for understanding cardiovascular disease. ADAS 3D exports information to multiple industry standard file formats suitable for documentation and information sharing purposes. The 3D data is exported into industry standard file formats supported by catheter navigation systems. ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support: - Visualization of the distribution of the enhancement in a three-dimensional (3D) chamber of the heart. - Quantification of the total volume of the enhancement within the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure. - Calculation, quantification and visualization of corridors of intermediate, signal intensity enhancement in the LV. - Quantification and visualization of the total area and distribution of the enhancement within the left Atrium (LA). Additionally, ADAS 3D imports DICOM CTA images to support: - Quantification of LV wall thickness. - Identification and Visualization of other 3D anatomical structures. - Quantification and visualization of LA wall thickness. - Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures. Additionally, ADAS 3D imports DICOM Magnetic Resonance Angiography (MRA) images to support: - Identification and Visualization of other 3D anatomical structures. It is designed to be used by qualified medical professionals (cardiologists, radiologists or trained technicians) experienced in examining and evaluating cardiovascular MR and CTA images as part of the comprehensive diagnostic decision-making process.

ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, radiologists, radiologists, or trained technicians) for the calculation quantification of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making. The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.

ADAS 3D is a stand-alone software tool designed for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D software aids in the non-invasive calculation, quantification and visualization of cardiac imaging data to support a comprehensive diagnostic decisionmaking process for understanding cardiovascular disease. ADAS 3D exports information to multiple industry standard file formats suitable for documentation and information sharing purposes. The 3D data is exported into industry standard file formats supported by catheter navigation systems. ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support: - Visualization of the distribution of the enhancement in a three-dimensional (3D) chamber of the heart. - Quantification of the total volume of the enhancement within the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure. - Calculation, quantification and visualization of corridors of intermediate, signal intensity enhancement in the LV. - Quantification and visualization of the total area and distribution of the enhancement within the left Atrium (LA). Additionally, ADAS 3D imports DICOM CTA images to support: - Quantification of LV wall thickness. - Identification and Visualization of other 3D anatomical structures. - Quantification and visualization of LA wall thickness. - Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures. It is designed to be used by qualified medical professionals (cardiologists, radiologists or trained technicians) experienced in examining and evaluating cardiovascular MR and CTA images as part of the comprehensive diagnostic decision-making process.

ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated to be used only by qualified medical professionals ( cardiologists, radiologists, radiologists, radiologists, or trained technicians) for the calculation and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making. The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias ( e.g., ventricular tachycardia) or risk stratification has not been established.

ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced Magnetic Resonance (MRI) images and Computed Tomography Angiography (CTA) images. ADAS 3D is designed to process DICOM image databases to enable the calculation, quantification and visualization of 3D cardiac imaging data by displaying and quantifying the levels of enhancement. ADAS 3D also enables the visualization of the shape of the cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard for viewing on other systems, including Electrophysiology (EP) navigation systems.