Cleared Special

K112751 - SDX-4343CS

K112751 is an FDA 510(k) clearance for SDX-4343CS, manufactured by Samsung Mobile Display Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 63-day FDA review.

K112751 · Samsung Mobile Display Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
63d
Days
Class 2
Risk

K112751 is an FDA 510(k) clearance for the SDX-4343CS. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Samsung Mobile Display Co., Ltd. (Houston, US). The FDA issued a Cleared decision on November 23, 2011 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112751

510(k) Number K112751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2011
Decision Date November 23, 2011
Days to Decision 63 days
Submission Type Special
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
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K112751.
REGIUS SIGMA2
K120131 · Konica Minolta Medical & Graphic, Inc. · Feb 2012
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
K111305 · Meridian Medical Systems, LLC · Jan 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630 · Rayence Co., Ltd. · Dec 2011
INFINIX-CCI
K113052 · Toshiba America Medical Systems, In.C · Nov 2011
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K112132 · Medicatech USA · Nov 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K112558 · Samsung Mobile Display Co., Ltd. · Nov 2011
K112751 · SDX-4343CS
Download PDF FDA Summary Samsung Mobile Displa…