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., Medical AI Co., Ltd. and Eko Health, Inc..
6
Total
6
Cleared
166d
Avg days
2023
Since
Growing category -
4 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
200d
recently vs 99d historically
FDA 510(k) Cleared Reduced Ejection Fraction Machine Learning-based Notification Software Devices (Product Code QYE)
6 devices
Cleared
Sep 30, 2026
ECG Analysis Software (AiTiALVSD)
Medical AI Co., Ltd.
Cardiovascular
273d
Cleared
Sep 19, 2025
Bunkerhill ECG-EF
BunkerHill Health
Cardiovascular
199d
Cleared
Jul 28, 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
Cardiovascular
146d
Cleared
Jul 15, 2025
Tempus ECG-Low EF
Tempus AI, Inc.
Cardiovascular
180d
Cleared
Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)
Eko Health, Inc.
Cardiovascular
174d
Cleared
Sep 28, 2023
Low Ejection Fraction AI-ECG Algorithm
Anumana, Inc.
Cardiovascular
23d
About Product Code QYE - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QYE since 2023, with 6 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QYE Product Code
Recent submissions under QYE have taken an average of 200 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 →