510(k) · Cleared
ClearedECG Analysis Software (AiTiALVSD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical AI Co., Ltd. · QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Cleared on Sep 30, 2026 as substantially equivalent to K250652 (Anumana, Inc., 2025) after a 273-day review. Its family tree reaches back 3 generations to 2023.
- Decided
- Sep 30, 2026
- Review
- 273 days
- Class
- Class II
- Product code
- QYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 3 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 2 generations backK232699 Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023
- 1 generation backK250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
- This deviceK254302 ECG Analysis Software (AiTiALVSD)Medical AI Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| −2 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023 | — |
| −1 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025 | — |
| 0 (this device) | K254302 | ECG Analysis Software (AiTiALVSD) | Medical AI Co., Ltd. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QYE device
- #1 K250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead…score 19.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Summary page 5…21 CFR § 870.2380 Product Code: QYE Predicate Device: Anumana, Inc. Low Ejection Fraction AI-ECG Algorithm Submission Number: K250652 Product Code: QYE Indications For Use AiTiALVSD is a software that utilizes artificial intelligence (AI) algor… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K250652.
How does its category compare?
All QYE devicesQYE Reduced Ejection Fraction Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QYE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYE
180in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QYE
No recall names QYE since 2007.
Adverse event reports per year · QYE
No MAUDE report names QYE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 180 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (185 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254302: ECG Analysis Software (AiTiALVSD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254302
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026