Cleared Traditional

K162497 - 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR

K162497 is an FDA 510(k) clearance for 5MP Monochrome LCD Monitor, manufactured by Eizo Corporation. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K162497 · Eizo Corporation · Radiology device
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Sep 2016
Decision
12d
Days
Class 2
Risk

K162497 is an FDA 510(k) clearance for the 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-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 September 19, 2016 after a review of 12 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

FDA 510(k) Submission Details - K162497

510(k) Number K162497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2016
Decision Date September 19, 2016
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
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 134
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K162497.
Nio Color 5.8MP (MDNC-6121)
K170476 · Barco N.V. · Mar 2017
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
K163335 · Eizo Corporation · Dec 2016
8MP Color LCD Monitor (C81W+)
K162527 · Shenzhen Beacon Display Technology Co., Ltd. · Sep 2016
2MP Color LCD Monitor CCL214 (CL21214)
K161895 · Jvckenwood Corporation · Sep 2016
Dell UP3216Q with QUBYX PerfectLum bundle
K162196 · Qubyx Software Technologies, Inc. · Aug 2016
Mammo Tomosynthesis (MDMG-5221)
K161229 · Barco N.V. · May 2016