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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Coronary Artery Disease Machine Learning-Based Notification Software

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2380

Medical specialty

Cardiovascular

FDA 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.

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