QXO — Cardiovascular Machine Learning-Based Notification Software Class II

FDA Device Classification

Classification Details

Product Code
QXO
Device Class
Class II
Regulation Number
870.2380
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN230003viz. aiViz HCMAugust 3, 2023