Cleared Traditional

K123105 - XGEO GU60

K123105 is an FDA 510(k) clearance for XGEO GU60, manufactured by Samsung Electronics Co., Ltd.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K123105

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.

KPR Device Classification - Class 2, Special Controls

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 271
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K123105.
YSIO MAX
K133259 · Siemens Medical Solutions USA, Inc. · Jan 2014
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
K132294 · Radiology Solutions, LLC · Nov 2013
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · Samsung Electronics Co., Ltd. · Jun 2013
CPI RAD VISION
K122726 · Communications & Power Industries Canada, Inc. · Feb 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