Cleared Traditional

K090742 - DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A

K090742 is an FDA 510(k) clearance for DIGITAL FLAT PANEL X-RAY DETECTOR, manufactured by Samsung Mobile Display Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K090742 · Samsung Mobile Display Co., Ltd. · Radiology device
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Sep 2009
Decision
182d
Days
Class 2
Risk

K090742 is an FDA 510(k) clearance for the DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A. 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 September 18, 2009 after a review of 182 days - an extended review 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: 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 Mobile Display Co., Ltd. devices

FDA 510(k) Submission Details - K090742

510(k) Number K090742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date September 18, 2009
Days to Decision 182 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 107d · This submission: 182d
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 294
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K090742.
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
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K092717 · Konica Minolta Medical & Graphic, Inc. · Oct 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238 · Agfa Healthcare N.V. · Aug 2009
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · Canon, Inc. · Jun 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · Canon, Inc. · May 2009