Cleared Traditional

K182183 - GC70, GU60A, GU60A-65, GF50, GR50A

Also marketed or referenced as:
GR40CW GM85 GC85A

K182183 is an FDA 510(k) clearance for GC70, 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 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

FDA 510(k) Submission Details - K182183

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.

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 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