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..
2
Total
1
Cleared
166d
Avg days
2023
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
126d
recently vs 205d historically
FDA 510(k) Cleared Cardiovascular Machine Learning-based Notification Software Devices (Product Code QXO)
2 devices
About Product Code QXO - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QXO since 2023, with 1 receiving FDA clearance (average review time: 166 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - QXO Product Code
Recent submissions under QXO have taken an average of 126 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
QXO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →