Cleared Traditional

8MP Color LCD Monitor, RadiForce RX850, RX850-AR

K152713 · Eizo Corporation · Radiology

Nov 2015

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K152713 is an FDA 510(k) clearance for the 8MP Color LCD Monitor, RadiForce RX850, RX850-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 November 20, 2015, 60 days after receiving the submission on September 21, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K152713 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2015
Decision Date	November 20, 2015
Days to Decision	60 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.