SIU

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Predictive Indicator For Long-Term Cardiovascular Outcomes

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2215

Medical specialty

Cardiovascular

FDA definition

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.

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