EPX-Series Mobile X-ray System— 510(k) K151038

Substantially Equivalent

Ecotron Co., Ltd.

FDA 510(k) clearance K151038 for EPX-Series Mobile X-ray System, Substantially Equivalent on 2015-07-24. Applicant: Ecotron Co., Ltd..

Clearance details

Applicant: Ecotron Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2015-04-20
Decision date: 2015-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.