# K254302: ECG Analysis Software (AiTiALVSD)

- Pathway: 510(k) (Traditional)
- Applicant: Medical AI Co., Ltd.
- Decided: Sep 30, 2026 after 273 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: 3 generations back to DEN230003 (2023). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010), Anumana, Inc. (2025) Summary page 5.

## Indications for use
AiTiALVSD is a software that utilizes artificial intelligence (AI) algorithms to support diagnosis of Left Ventricular Systolic Dysfunction (LVSD). AiTiALVSD is intended to assess LVSD, defined as a Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%, in adults at risk for heart failure using 12-lead ECG data. AiTiALVSD is meant for use in professional medical facilities by qualified clinicians. The software is indicated for use on adults only. When the results (High or Low) from AiTiALVSD are applied in a clinical setting to an individual patient's ECG data, they can assist in clinical decision-making regarding patient diagnosis. However, these results should be used in conjunction with other clinical data and should not be the sole determinant for a clinical diagnosis. The target population includes adults at risk for heart failure. This population includes, but is not limited to, individuals with coronary artery disease, diabetes mellitus, cardiomyopathies, hypertension, obesity; history of myocardial infarction; aortic stenosis; atrial fibrillation; exposure to cardiotoxic pharmaceutical therapies; cardiac hypertrophy evident in chest X-rays; and postpartum women. Additionally, AiTiALVSD should not be used on ECGs with a paced rhythm.

Source page: https://510kreport.com/device/K254302
Methodology: https://510kreport.com/methodology