Cleared Traditional

K140334 - XGEO GC80 (FDA 510(k) Clearance)

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

K140334 · Samsung Electronics Co., Ltd. · Radiology device
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May 2014
Decision
107d
Days
Class 2
Risk

K140334 is an FDA 510(k) clearance for the XGEO GC80. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on May 28, 2014 after a review of 107 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 K140334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date May 28, 2014
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
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.

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