Cleared Abbreviated

RadiForce RX570; RadiForce RX570-AR

K243221 · Eizo Corporation · Radiology

Nov 2024

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K243221 is an FDA 510(k) clearance for the RadiForce RX570; RadiForce RX570-AR, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on November 27, 2024, 51 days after receiving the submission on October 7, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K243221 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 2024
Decision Date	November 27, 2024
Days to Decision	51 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.