510(k) clearance
ECG Analysis Software (AiTiALVSD)
- 510(k) number
- K254302
- Applicant
- Medical AI Co., Ltd.
- Decision date
- Sep 30, 2026
- Date received
- Dec 31, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QYE
- Device type
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Device class
- Class II
- Regulation
- 21 CFR 870.2380
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Gangnam-Gu, Seoul, KR