DeviceClearance

Product code QXO— Cardiovascular

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Classification name
Cardiovascular Machine Learning-Based Notification Software
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QXO under 21 CFR 870.2380, via openFDA

Market context for product code QXO

FDA has cleared 2 devices under product code QXO between 2023 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QXO

Recent clearances under product code QXO

Data sourced from openFDA. This site is unofficial and independent of the FDA.