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QXOClass II

Cardiovascular Machine Learning-Based Notification Software

21 CFR 870.2380 / Cardiovascular
FDA source (opens on fda.gov)

QXO is the FDA product code for Cardiovascular Machine Learning-Based Notification Software, a class II device type, regulated under 21 CFR 870.2380. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QXO
Device name
Cardiovascular Machine Learning-Based Notification Software
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.
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QXO

By decision year
2 clearances under product code QXO with a decision year between 2023 and 2026, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXO by decision year
YearClearances
20231
20261

Applicants with the most clearances

Product code QXO
Applicants holding the most 510(k) clearances under product code QXO
ApplicantClearances
Pathwai, Inc1
Viz. Ai, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code