Cleared Traditional

K163115 - GC70

K163115 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 30-day FDA review.

K163115 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
30d
Days
Class 2
Risk

K163115 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 December 7, 2016 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Samsung Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K163115

510(k) Number K163115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date December 07, 2016
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 K163115.
HF 718BD X-Ray System
K160857 · Arquilla, Inc. Dba X-Cel X-Ray Corporation · Feb 2017
DigitalDiagnost C50
K163410 · Philips Healthcare (Suzhou) Co., Ltd. · Jan 2017
Carestream DRX-Evolution
K163203 · Carestream Health, Inc. · Dec 2016
FS-500DDR Medical Radiographic X-Ray System
K152813 · Orich Medical Equipment (Tianjin Co., Ltd. · Dec 2016
Multix Fusion Max
K162971 · Siemens Medical Solutions USA, Inc. · Nov 2016
CuattroDR
K161937 · Cuattro, LLC · Oct 2016