Cleared Traditional

2.3MP Color LCD Monitor, RadiForce MX242W

K143261 · Eizo Corporation · Radiology

Nov 2014

Decision

Days

Class 2

Risk

About This 510(k) Submission

K143261 is an FDA 510(k) clearance for the 2.3MP Color LCD Monitor, RadiForce MX242W, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on November 21, 2014, 8 days after receiving the submission on November 13, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K143261 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2014
Decision Date	November 21, 2014
Days to Decision	8 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.