Cleared Abbreviated

RadiForce RX270

K223768 · Eizo Corporation · Radiology

Apr 2023

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K223768 is an FDA 510(k) clearance for the RadiForce RX270, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on April 20, 2023, 126 days after receiving the submission on December 15, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K223768 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2022
Decision Date	April 20, 2023
Days to Decision	126 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.