Cleared Traditional

K140235 - XGEO GR40CW

K140235 is the FDA 510(k) clearance for XGEO GR40CW by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K140235 · Samsung Electronics Co., Ltd. · Radiology device
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May 2014
Decision
105d
Days
Class 2
Risk

K140235 is an FDA 510(k) clearance for the XGEO GR40CW. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on May 15, 2014 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K140235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date May 15, 2014
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K140235.
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DIGITAL DENTAL INTRA ORAL SENSOR
K140056 · Rayence Co., Ltd. · May 2014
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K140060 · Rayence Co., Ltd. · May 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K140646 · Rayence Co., Ltd. · Apr 2014