Cleared Special

K182647 - GC70

K182647 is the FDA 510(k) clearance for GC70 by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Special 510(k) pathway after a 30-day FDA review.

K182647 · Samsung Electronics Co., Ltd. · Radiology device
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Oct 2018
Decision
30d
Days
Class 2
Risk

K182647 is an FDA 510(k) clearance for the GC70. 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 October 24, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K182647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date October 24, 2018
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K182647.
GC70, GU60A, GU60A-65, GF50, GR50A
K182183 · Samsung Electronics Co., Ltd. · Dec 2018
ARiX RAD Radiographic System
K182134 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Nov 2018
Halifax Imaging Kit
K182880 · Halifax Biomedical, Inc. · Oct 2018
GU60A, GU60A-65
K182622 · Samsung Electronics Co., Ltd. · Oct 2018
GC85A
K181629 · Samsung Electronics Co., Ltd. · Jul 2018
uDR 592h, uDR 596i
K181413 · Shanghai United Imaging Healthcare Co., Ltd. · Jun 2018