QYE

Reduced Ejection Fraction Machine Learning-Based Notification Software

Product code

QYE

Device name

Reduced Ejection Fraction Machine Learning-Based Notification Software

Device class

Class 2

21 CFR

21 CFR 870.2380

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

5

Summaries archived here

5 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2025-09-19.

5 summaries are archived here for direct download.