Cleared Traditional

K163335 - 6MP Color LCD Monitor

K163335 is the FDA 510(k) clearance for 6MP Color LCD Monitor by Eizo Corporation. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K163335 · Eizo Corporation · Radiology device
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Dec 2016
Decision
17d
Days
Class 2
Risk

K163335 is an FDA 510(k) clearance for the 6MP Color LCD Monitor, RadiForce RX660, RX660-AR. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on December 15, 2016 after a review of 17 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 Eizo Corporation devices

Submission Details

510(k) Number K163335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2016
Decision Date December 15, 2016
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K163335.
Nio Color 2MP (MDNC-2123)
K171812 · Barco N.V. · Jul 2017
Nio Color 3MP (MDNC-3421)
K170837 · Barco N.V. · Apr 2017
Nio Color 5.8MP (MDNC-6121)
K170476 · Barco N.V. · Mar 2017
Mammo Tomosynthesis (MDMG-5221)
K161229 · Barco N.V. · May 2016
Coronis Uniti
K151505 · Barco N.V. · Jul 2015
Mammography Color Display DP-M3010
K143718 · Canon, Inc. · Jan 2015