Cleared Abbreviated

K181609 - RadiForce GX560, GX560-AR

K181609 is an FDA 510(k) clearance for RadiForce GX560, manufactured by Eizo Corporation. The device is a Class 2 Radiology device with product code PGY cleared through the Abbreviated 510(k) pathway after a 66-day FDA review.

K181609 · Eizo Corporation · Radiology device
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Aug 2018
Decision
66d
Days
Class 2
Risk

K181609 is an FDA 510(k) clearance for the RadiForce GX560, GX560-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 August 24, 2018 after a review of 66 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Eizo Corporation devices

FDA 510(k) Submission Details - K181609

510(k) Number K181609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2018
Decision Date August 24, 2018
Days to Decision 66 days
Submission Type Abbreviated
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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Standards-based clearance path.

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 K181609.
6MP Color LCD Monitor (C61W+)
K182291 · Shenzhen Beacon Display Technology Co., Ltd. · Nov 2018
RadiForce RX360, RX360-AR
K182591 · Eizo Corporation · Oct 2018
2MP Color LCD Monitor CL-R211
K182539 · Jvckenwood Corporation · Oct 2018
RadiForce MX194
K180961 · Eizo Corporation · May 2018
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
K173434 · Jvckenwood Corporation · Dec 2017
RadiForce RX560, RX560-AR
K172738 · Eizo Corporation · Nov 2017