Cleared Traditional

K150097 - GM60A-32S & GM60A-40S

K150097 is the FDA 510(k) clearance for GM60A-32S & GM60A-40S by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K150097 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
30d
Days
Class 2
Risk

K150097 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, KR). The FDA issued a Cleared decision on February 19, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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: 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 K150097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date February 19, 2015
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.

Device Classification

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 117
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K150097.
Digital Diagnostic Mobile X-ray System
K162278 · Samsung Electronics Co., Ltd. · Nov 2016
Optima XR240amx
K162990 · Ge Medical Systems, LLC · Nov 2016
Sirius Starmobile tiara
K143537 · Hitachi Medical Systems America, Inc. · Mar 2015
GM60A-32S, GM60A-40S
K142492 · Samsung Electronics Co., Ltd. · Dec 2014
Optima XR200amx, Optima XR220amx
K142383 · Ge Medical Systems, LLC · Sep 2014
DRX-REVOLUTION MOBILE X-RAY SYSTEM
K120062 · Carestream Health, Inc. · Apr 2012