Cleared Abbreviated

RadiForce MX194

K180961 · Eizo Corporation · Radiology

May 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K180961 is an FDA 510(k) clearance for the RadiForce MX194, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on May 10, 2018, 28 days after receiving the submission on April 12, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K180961 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2018
Decision Date	May 10, 2018
Days to Decision	28 days
Submission Type	Abbreviated
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.