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HeartSee version 4 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity. HeartSee version 4 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The climician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

HeartSee version 4 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee version 4 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. HeartSee version 4 contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the HeartSee version 4 software quantifies regional absolute rest and stress myocardial perfusion per unit tissue (ml/min/g), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio, and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values. HeartSee version 3 (K202679) and version 4 also display stress subendocardial to subepicardial ratio, subendocardial stress to rest ratio on relative activity tomograms and stress relative topogram maps expressed as a fraction of maximum ml/min/g, called relative stress flow (RSF). Archiving output data is supported for clinical diagnostics, quality control and research. In addition to these established measurements of perfusion in ml/min/g. CFR and CFC approved by FDA for K202679, HeartSee version 4 has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF by the precedent FDA approved Emory Cardiac Toolbox version V4.1.7786.35544.

HeartSee version 3 software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in ml/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity. HeartSee version 3 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

HeartSee version 3 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee version 3 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. HeartSee version 3 contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the HeartSee version 3 software quantifies regional absolute rest and stress myocardial perfusion per unit tissue (ml/min/q), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio, and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values, Archiving output data is supported for clinical diagnostics, quality control and research. In addition to these established measurements of perfusion in ml/min/g, CFR and CFC approved by FDA for K171303, HeartSee version 3 has the following additional clinically relevant displays. For explaining uncommon patients with angina or ST depression ≥1mm during stress PET imaging in the absence of severe perfusion defects, HeartSee version 3 has the following three additional displays: - 1. Stress subendocardial to subepicardial ratio on relative activity tomograms. - 2. Subendocardial stress to rest ratio on relative activity tomograms - 3. Stress relative topogram maps expressed as a fraction of maximum ml/min/g and called relative stress flow (RSF).