Cleared Traditional

K182183 - GC70

Also marketed or referenced as:
GR40CW GM85 GC85A

K182183 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 Traditional 510(k) pathway after a 116-day FDA review.

K182183 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
116d
Days
Class 2
Risk

K182183 is an FDA 510(k) clearance for the GC70, GU60A, GU60A-65, GF50, GR50A. 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 December 7, 2018 after a review of 116 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

Submission Details

510(k) Number K182183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2018
Decision Date December 07, 2018
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K182183.
MasteRad MX30
K190601 · Medicatech USA · Apr 2019
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
K183541 · Prognosys Medical Systems Private Limited · Jan 2019
MULTIX Impact
K182517 · Siemens Medi Cal Solutions, Inc. · Jan 2019
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
GC70
K182647 · Samsung Electronics Co., Ltd. · Oct 2018