ECG Analysis Software (AiTiALVSD)— 510(k) K254302
Substantially EquivalentMedical AI Co., Ltd.
FDA 510(k) clearance K254302 for ECG Analysis Software (AiTiALVSD), Substantially Equivalent on 2026-09-30. Applicant: Medical AI Co., Ltd.. Device class: 2.
Summary
ECG Analysis Software (AiTiALVSD) is filed under QYE, reduced ejection fraction machine learning-based notification software. That code covers software that uses machine learning to flag patients who may have a reduced ejection fraction. The device name says the input is ECG data; the record doesn't describe the algorithm or its outputs beyond that.
Class II, 21 CFR 870.2380. The Cardiovascular panel reviewed it as a Traditional 510(k).
Medical AI Co., Ltd. filed from Gangnam-Gu, Seoul, South Korea. Review took 273 days (December 31, 2025 to September 30, 2026). The record doesn't explain the length of the clock.
Clearance details
- Applicant
- Medical AI Co., Ltd.
- Product code
- Product code QYE
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gangnam-Gu, Seoul, KR
Recent devices under product code QYE
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