Cleared Traditional

K123098 - XGEO GC80

K123098 is an FDA 510(k) clearance for XGEO GC80, 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 108-day FDA review.

K123098 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
108d
Days
Class 2
Risk

K123098 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. (Echo, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 108 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

FDA 510(k) Submission Details - K123098

510(k) Number K123098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2012
Decision Date January 18, 2013
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
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 K123098.
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · Samsung Electronics Co., Ltd. · Jun 2013
XGEO GU60
K123105 · Samsung Electronics Co., Ltd. · Jun 2013
CPI RAD VISION
K122726 · Communications & Power Industries Canada, Inc. · Feb 2013
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
K122454 · Fujifilm Medical System U.S.A., Inc. · Nov 2012
DFP4343C7
K122589 · Mdi Consultants, Inc. · Oct 2012
DX-D FULL LEG FULL SPINE
K122119 · Afga Healthcare N.V. · Sep 2012