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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device predictive indicator for long-term cardiovascular outcomes
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.
Product CodeSIU
Regulation Number 870.2215
Device Class 2


Premarket Reviews
ManufacturerDecision
CARISTO DIAGNOSTICS , LTD.
  GRANTED 1

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