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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2380
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K250649BunkerHill Health · 510k2025-09-19
K250652Anumana, Inc. · 510k2025-07-28
K250119Tempus AI, Inc. · 510k2025-07-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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