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Device cardiovascular machine learning-based notification software
Definition Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.
Product CodeQXO
Regulation Number 870.2380
Device Class 2


Premarket Reviews
ManufacturerDecision
VIZ.AI, INC.
  GRANTED 1

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