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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device coronary artery disease machine learning-based notification software
Definition Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.
Product CodeQXX
Regulation Number 870.2380
Device Class 2


Premarket Reviews
ManufacturerDecision
CORVISTA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

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