Cleared Traditional

5MP Monochrome LCD Monitor, RadiForce GX540

K151883 · Eizo Corporation · Radiology

Jul 2015

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K151883 is an FDA 510(k) clearance for the 5MP Monochrome LCD Monitor, RadiForce GX540, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on July 30, 2015, 21 days after receiving the submission on July 9, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K151883 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2015
Decision Date	July 30, 2015
Days to Decision	21 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.