Cleared Traditional

K234108 - ERI Portable X-ray System (CVX-air)

Also marketed or referenced as:
ERI Portable X-ray System (CVX-lite) ERI Portable X-ray System (CVX-E)

K234108 is an FDA 510(k) clearance for ERI Portable X-ray System (CVX-air), manufactured by Energy Resources International Co., Ltd.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K234108 · Energy Resources International Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
268d
Days
Class 2
Risk

K234108 is an FDA 510(k) clearance for the ERI Portable X-ray System (CVX-air). Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Energy Resources International Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on September 20, 2024 after a review of 268 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Energy Resources International Co., Ltd. devices

FDA 510(k) Submission Details - K234108

510(k) Number K234108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2023
Decision Date September 20, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 107d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 130
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K234108.
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