Cleared Traditional

6MP Color LCD Monitor, RadiForce RX660, RX660-AR

K163335 · Eizo Corporation · Radiology

Dec 2016

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K163335 is an FDA 510(k) clearance for the 6MP Color LCD Monitor, RadiForce RX660, RX660-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 December 15, 2016, 17 days after receiving the submission on November 28, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K163335 FDA.gov
FDA Decision	Cleared 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

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.