Cleared Abbreviated

RadiForce GX560, GX560-AR

K181609 · Eizo Corporation · Radiology

Aug 2018

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K181609 is an FDA 510(k) clearance for the RadiForce GX560, GX560-AR, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on August 24, 2018, 66 days after receiving the submission on June 19, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K181609 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PGY — Display, Diagnostic Radiology
Device Class	Class II — 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.