Cleared Traditional

K123105 - XGEO GU60

K123105 is the FDA 510(k) clearance for XGEO GU60 by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K123105 · Samsung Electronics Co., Ltd. · Radiology device
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Jun 2013
Decision
248d
Days
Class 2
Risk

K123105 is an FDA 510(k) clearance for the XGEO GU60. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Echo, US). The FDA issued a Cleared decision on June 7, 2013 after a review of 248 days - an extended review cycle.

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 K123105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2012
Decision Date June 07, 2013
Days to Decision 248 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
141d slower than avg
Panel avg: 107d · This submission: 248d
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.

Regulatory Peers - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K123105.
MULTIX SELECT DR
K132934 · Siemens Medi Cal Solutions, Inc. · Apr 2014
YSIO MAX
K133259 · Siemens Medical Solutions USA, Inc. · Jan 2014
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · Samsung Electronics Co., Ltd. · Jun 2013
XGEO GC80
K123098 · Samsung Electronics Co., Ltd. · Jan 2013
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
K122454 · Fujifilm Medical System U.S.A., Inc. · Nov 2012
BRIVO XR385
K103448 · Ge Medical Systems, LLC · Aug 2011