Cleared Traditional

K173828 - GU60A & GU60A-65

K173828 is the FDA 510(k) clearance for GU60A & GU60A-65 by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K173828 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
25d
Days
Class 2
Risk

K173828 is an FDA 510(k) clearance for the GU60A & GU60A-65. 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 January 12, 2018 after a review of 25 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

Submission Details

510(k) Number K173828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2017
Decision Date January 12, 2018
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 169
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K173828.
RADspeed fit
K173517 · Shimadzu Corporation · Mar 2018
Amrad Medical AAU Digital Radiography System
K173823 · Summit Industries, LLC · Feb 2018
uDR 780i
K173953 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2018
GC85A
K172229 · Samsung Electronics Co., Ltd. · Nov 2017
Carestream DRX-Evolution
K163203 · Carestream Health, Inc. · Dec 2016
GC70
K163115 · Samsung Electronics Co., Ltd. · Dec 2016