510(k) K254302 ยท QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
ECG Analysis Software (AiTiALVSD)
| Applicant | Medical AI Co., Ltd., Gangnam-Gu, Seoul, KR |
| Decision | Substantially Equivalent, Sep 30, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254302
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.