Cleared Traditional

K150145 - MD322C8 31.5 Diagnostic Imaging LCD Monitor

K150145 is an FDA 510(k) clearance for MD322C8 31.5 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 15-day FDA review.

K150145 · Nec Display Solutions , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
15d
Days
Class 2
Risk

K150145 is an FDA 510(k) clearance for the MD322C8 31.5 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 February 6, 2015 after a review of 15 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 - K150145

510(k) Number K150145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2015
Decision Date February 06, 2015
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 K150145.
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