Cleared Traditional

K132587 - MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR

K132587 is an FDA 510(k) clearance for MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR, manufactured by Ned Display Solutions , Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K132587 · Ned Display Solutions , Ltd. · Radiology device
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Aug 2013
Decision
13d
Days
Class 2
Risk

K132587 is an FDA 510(k) clearance for the MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Ned Display Solutions , Ltd. (Tokyo, JP). The FDA issued a Cleared decision on August 29, 2013 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ned Display Solutions , Ltd. devices

FDA 510(k) Submission Details - K132587

510(k) Number K132587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2013
Decision Date August 29, 2013
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1244
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