QXO · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2380
Classification
FDA Product Code
QXO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2380
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.