FDA Product Code SBQ: Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software
Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Future Occurrence Of Atrial Fibrillation For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Tempus AI, Inc..
FDA 510(k) Cleared Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Devices (Product Code SBQ)
About Product Code SBQ - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBQ since 2024, with 1 receiving FDA clearance (average review time: 231 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →