FDA Product Code QYE: Reduced Ejection Fraction Machine Learning-based Notification Software
Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Anumana, Inc., Eko Health, Inc. and Tempus AI, Inc..
FDA 510(k) Cleared Reduced Ejection Fraction Machine Learning-based Notification Software Devices (Product Code QYE)
About Product Code QYE - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QYE since 2023, with 5 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QYE have taken an average of 175 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
QYE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →