QXO

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Cardiovascular Machine Learning-Based Notification Software

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2380

Medical specialty

Cardiovascular

FDA 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.

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