Predictive Indicator For Long-Term Cardiovascular Outcomes
FDA product code SIU · Class II (moderate risk) · 21 CFR 870.2215 · Cardiovascular
The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease.
0510(k) clearances
0PMA approvals
0recalls