QXO · Class II · 21 CFR 870.2380

FDA Product Code QXO: Cardiovascular Machine Learning-based Notification Software

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.

Leading manufacturers include Viz. Ai, Inc..

1
Total
0
Cleared
205d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cardiovascular Machine Learning-based Notification Software Devices (Product Code QXO)

1 devices
1–1 of 1
Not Cleared Aug 03, 2023
Viz HCM
DEN230003
Viz. Ai, Inc.
Cardiovascular · 205d

About Product Code QXO - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXO since 2023, with 0 receiving FDA clearance (average review time: 205 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →