ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)— 510(k) K234108

Substantially Equivalent

Energy Resources International Co., Ltd.

FDA 510(k) clearance K234108 for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E), Substantially Equivalent on 2024-09-20. Applicant: Energy Resources International Co., Ltd..

Clearance details

Applicant: Energy Resources International Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2023-12-27
Decision date: 2024-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

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.