Cleared Traditional

K172229 - GC85A

K172229 is an FDA 510(k) clearance for GC85A, 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 120-day FDA review.

K172229 · Samsung Electronics Co., Ltd. · Radiology device
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Nov 2017
Decision
120d
Days
Class 2
Risk

K172229 is an FDA 510(k) clearance for the GC85A. 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 November 22, 2017 after a review of 120 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 - K172229

510(k) Number K172229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date November 22, 2017
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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 264
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K172229.
uDR 780i
K173953 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2018
GU60A & GU60A-65
K173828 · Samsung Electronics Co., Ltd. · Jan 2018
Optima XR646 HD
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Discovery XR656 HD
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DigiX FDX
K162529 · Allengers Medical Systems Limited · Mar 2017
HF 718BD X-Ray System
K160857 · Arquilla, Inc. Dba X-Cel X-Ray Corporation · Feb 2017