Cleared Abbreviated

RadiForce MX216

K190153 · Eizo Corporation · Radiology

Mar 2019

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K190153 is an FDA 510(k) clearance for the RadiForce MX216, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on March 8, 2019, 37 days after receiving the submission on January 30, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K190153 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2019
Decision Date	March 08, 2019
Days to Decision	37 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.