Cleared Traditional

K143029 - Digital Diagnostic X-ray System (GC80)

K143029 is an FDA 510(k) clearance for Digital Diagnostic X-ray System (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 106-day FDA review.

K143029 · Samsung Electronics Co., Ltd. · Radiology device
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Feb 2015
Decision
106d
Days
Class 2
Risk

K143029 is an FDA 510(k) clearance for the Digital Diagnostic X-ray System (GC80). Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on February 4, 2015 after a review of 106 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 - K143029

510(k) Number K143029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2014
Decision Date February 04, 2015
Days to Decision 106 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 faster than avg
Panel avg: 107d · This submission: 106d
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 266
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K143029.
DRX-EVOLUTION
K141837 · Carestream Health, Inc. · Mar 2015
Optima XR646
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K143257 · Medicatech USA · Feb 2015
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EOS System
K142773 · Eos Imaging · Jan 2015
MULTIX FUSION VA30 & VA40
K142049 · Siemens Medical Solutions USA, Inc. · Dec 2014