FDA Product Code QXX: Coronary Artery Disease Machine Learning-based Notification Software
Coronary Artery Disease Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Coronary Artery Disease For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Corvista Health, Inc..
1
Total
1
Cleared
7d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Coronary Artery Disease Machine Learning-based Notification Software Devices (Product Code QXX)
1 devices
About Product Code QXX - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QXX since 2023, with 1 receiving FDA clearance (average review time: 7 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QXX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →