Cleared Traditional

K142492 - GM60A-32S, GM60A-40S

K142492 is an FDA 510(k) clearance for GM60A-32S, manufactured by Samsung Electronics Co., Ltd.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K142492 · Samsung Electronics Co., Ltd. · Radiology device
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Dec 2014
Decision
104d
Days
Class 2
Risk

K142492 is an FDA 510(k) clearance for the GM60A-32S, GM60A-40S. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on December 17, 2014 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 - K142492

510(k) Number K142492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2014
Decision Date December 17, 2014
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 176
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K142492.
EPX-Series Mobile X-ray System
K151038 · Ecotron Co., Ltd. · Jul 2015
Sirius Starmobile tiara
K143537 · Hitachi Medical Systems America, Inc. · Mar 2015
GM60A-32S & GM60A-40S
K150097 · Samsung Electronics Co., Ltd. · Feb 2015
KUBTEC X250
K141539 · Kub Technologies, Inc. · Oct 2014
Optima XR200amx, Optima XR220amx
K142383 · Ge Medical Systems, LLC · Sep 2014
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
K141885 · Minxray, Inc. · Sep 2014