Cleared Traditional

K102587 - LLX240AB01

K102587 is an FDA 510(k) clearance for LLX240AB01, 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 83-day FDA review.

K102587 · Samsung Mobile Display Co., Ltd. · Radiology device
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Dec 2010
Decision
83d
Days
Class 2
Risk

K102587 is an FDA 510(k) clearance for the LLX240AB01. 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. (Secaucus, US). The FDA issued a Cleared decision on December 1, 2010 after a review of 83 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 Mobile Display Co., Ltd. devices

FDA 510(k) Submission Details - K102587

510(k) Number K102587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2010
Decision Date December 01, 2010
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
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 K102587.
REGUIS SIGMA
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