Cleared Traditional

K142951 - MD210C3 21.3 Diagnostic Imaging LCD Monitor

K142951 is an FDA 510(k) clearance for MD210C3 21.3 Diagnostic Imaging LCD Monitor, manufactured by Nec Display Solutions , Ltd.. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K142951 · Nec Display Solutions , Ltd. · Radiology device
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Dec 2014
Decision
61d
Days
Class 2
Risk

K142951 is an FDA 510(k) clearance for the MD210C3 21.3 Diagnostic Imaging LCD Monitor. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Nec Display Solutions , Ltd. (Tokyo, JP). The FDA issued a Cleared decision on December 10, 2014 after a review of 61 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: 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 Nec Display Solutions , Ltd. devices

FDA 510(k) Submission Details - K142951

510(k) Number K142951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2014
Decision Date December 10, 2014
Days to Decision 61 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
46d faster than avg
Panel avg: 107d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGY Device Classification - Class 2, Special Controls

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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 - PGY Display, Diagnostic Radiology

All 120
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K142951.
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