Cleared Abbreviated

RadiForce MX243W

K221136 · Eizo Corporation · Radiology

May 2022

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K221136 is an FDA 510(k) clearance for the RadiForce MX243W, 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, 2022, 21 days after receiving the submission on April 19, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K221136 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2022
Decision Date	May 10, 2022
Days to Decision	21 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.