Cleared Traditional

K153401 - GR40CW

K153401 is an FDA 510(k) clearance for GR40CW, manufactured by Samsung Electronics Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K153401 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
27d
Days
Class 2
Risk

K153401 is an FDA 510(k) clearance for the GR40CW. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si,, KR). The FDA issued a Cleared decision on December 21, 2015 after a review of 27 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 - K153401

510(k) Number K153401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date December 21, 2015
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 389
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K153401.
VIVIX-S 1717N
K152894 · Vieworks Co., Ltd. · Feb 2016
CareView 1800L
K153492 · Careray Digital Medical System Co., Ltd. · Dec 2015
Philips Eleva Workspot with SkyFlow
K153318 · Philips Medical Systems Dmc GmbH · Dec 2015
DR 600
K152639 · Agfa Healthcare N.V. · Dec 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142 · Carestream Health, Inc. · Nov 2015
ATAL 9
K152151 · Atlaim Corporation · Nov 2015