Cleared Traditional

K143494 - ADX6000 Portable X-Ray System

Also marketed or referenced as:
iRayA6

K143494 is an FDA 510(k) clearance for ADX6000 Portable X-Ray System, manufactured by Dexcowin Co., Ltd.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K143494 · Dexcowin Co., Ltd. · Radiology device
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Oct 2015
Decision
300d
Days
Class 2
Risk

K143494 is an FDA 510(k) clearance for the ADX6000 Portable X-Ray System. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Dexcowin Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on October 5, 2015 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Dexcowin Co., Ltd. devices

FDA 510(k) Submission Details - K143494

510(k) Number K143494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2014
Decision Date October 05, 2015
Days to Decision 300 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 107d · This submission: 300d
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 Consultant

Denterprise International, Inc.
Claude Berthoin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZL System, X-ray, Mobile

All 175
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