Cleared Traditional

K151038 - EPX-Series Mobile X-ray System

K151038 is an FDA 510(k) clearance for EPX-Series Mobile X-ray System, manufactured by Ecotron Co., Ltd.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K151038 · Ecotron Co., Ltd. · Radiology device
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Jul 2015
Decision
95d
Days
Class 2
Risk

K151038 is an FDA 510(k) clearance for the EPX-Series Mobile X-ray System. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Ecotron Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 24, 2015 after a review of 95 days - within the typical 510(k) review window.

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 Ecotron Co., Ltd. devices

FDA 510(k) Submission Details - K151038

510(k) Number K151038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date July 24, 2015
Days to Decision 95 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
12d faster than avg
Panel avg: 107d · This submission: 95d
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 133
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K151038.
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