Cleared Traditional

K234108 - ERI Portable X-ray System (CVX-air) (FDA 510(k) Clearance)

Also includes:
ERI Portable X-ray System (CVX-lite) ERI Portable X-ray System (CVX-E)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 233
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