# ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 61/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254302 |
| Device | ECG Analysis Software (AiTiALVSD) |
| Applicant | Medical AI Co., Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | QYE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-31 |
| Decision date | 2026-09-30 |
| Review time (days) | 273 |
| Third-party review | No |
| Applicant location | Gangnam-Gu, Seoul, KR |

## Why this score
- A long 273-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 35 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254302). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.