Cleared Traditional

3MP Color LCD Monitor, RadiForce RX350

K153354 · Eizo Corporation · Radiology

Jan 2016

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K153354 is an FDA 510(k) clearance for the 3MP Color LCD Monitor, RadiForce RX350, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on January 12, 2016, 53 days after receiving the submission on November 20, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K153354 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2015
Decision Date	January 12, 2016
Days to Decision	53 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.