Cleared Traditional

K082875 - PORTABLE X-RAY SYSTEM, MODEL DXR -1

K082875 is an FDA 510(k) clearance for PORTABLE X-RAY SYSTEM, manufactured by Exaro Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K082875 · Exaro Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
129d
Days
Class 2
Risk

K082875 is an FDA 510(k) clearance for the PORTABLE X-RAY SYSTEM, MODEL DXR -1. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Exaro Co., Ltd. (Salt Lake City, US). The FDA issued a Cleared decision on February 5, 2009 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Exaro Co., Ltd. devices

FDA 510(k) Submission Details - K082875

510(k) Number K082875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date February 05, 2009
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 106
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K082875.
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PORTABLE X-RAY SYSTEM, MODEL PORT-X II
K063121 · Genoray Co., Ltd. · Jan 2007
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · Planmeca Oy · Jun 2005