Cleared Abbreviated

RadiForce GX570; RadiForce GX570-AR

K252030 · Eizo Corporation · Radiology

Aug 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K252030 is an FDA 510(k) clearance for the RadiForce GX570; RadiForce GX570-AR, 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 August 28, 2025, 59 days after receiving the submission on June 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K252030 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	August 28, 2025
Days to Decision	59 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.