ERI Portable X-ray System (3 models)— 510(k) K234108

Name: FDA 510(k) clearance K234108
Creator: U.S. Food and Drug Administration
Published: 2024-09-20

Substantially Equivalent

Energy Resources International Co., Ltd.

FDA 510(k) clearance K234108 for ERI Portable X-ray System (3 models), Substantially Equivalent on 2024-09-20. Applicant: Energy Resources International Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)
Applicant: Energy Resources International Co., Ltd.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
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 ↗

Recent devices under product code IZL

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K260236 — XLITE2026-08-03
K253058 — Portable DR Imaging System2026-06-18
K260085 — RAYMO Mobile X-ray System (Model: RAYMO)2026-05-14
K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System2026-03-11
K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)2026-02-23

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.