Cleared Abbreviated

RadiForce MX317W

K233465 · Eizo Corporation · Radiology

Dec 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K233465 is an FDA 510(k) clearance for the RadiForce MX317W, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, Ishikawa, JP). The FDA issued a Cleared decision on December 21, 2023, 58 days after receiving the submission on October 24, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K233465 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2023
Decision Date	December 21, 2023
Days to Decision	58 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.