510(k) K213462— EzRay M18 (Model: VMX-P400)

Substantially Equivalent

VATECH Co., Ltd.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2021-10-27
Decision date: 2022-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

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.