Device typeCardiopulmonary physiological parameter analysis software, professional-only: A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.
FDA categoryAortic Stenosis Machine Learning-Based Notification Software, Cardiac Hypertrophy Machine Learning-Based Notification Software, Cardiovascular Machine Learning-Based Notification Software, Pulmonary Hypertension Machine Learning-Based Notification Software, Reduced Ejection Fraction Machine Learning-Based Notification Software, Valvular Regurgitation Machine Learning-Based Notification Software
Device ID00860016080300
MRI safetyLabeling does not contain MRI Safety Information