# K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

- Pathway: 510(k) (Traditional)
- Applicant: Anumana, Inc.
- Decided: Jul 28, 2025 after 146 days
- Product code: QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN230003 (2023). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232699: Low Ejection Fraction AI-ECG Algorithm, Anumana, Inc. (2023) Summary page 5.

## Most influential descendants
- K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (2026), 1 descendant of its own
- K254302: ECG Analysis Software (AiTiALVSD) (2026), 0 descendants of its own
- K254297: Tempus ECG-MR (2026), 0 descendants of its own
- K253801: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (2026), 0 descendants of its own

## Indications for use
The ECG-AI LEF 12-Lead algorithm is software intended to aid in earlier detection of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for heart failure. This population includes, but is not limited to: • patients with cardiomyopathies • patients who are post-myocardial infarction • patients with aortic stenosis • patients with chronic atrial fibrillation • patients receiving pharmaceutical therapies that are cardiotoxic, and • postpartum women. The ECG-AI LEF 12-Lead algorithm is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation. The ECG-AI LEF 12-Lead algorithm should be applied jointly with clinician judgment.

Source page: https://510kreport.com/device/K250652
Methodology: https://510kreport.com/methodology