Cleared Abbreviated

RadiForce RX370

K211491 · Eizo Corporation · Radiology

Jul 2021

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K211491 is an FDA 510(k) clearance for the RadiForce RX370, a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on July 12, 2021, 60 days after receiving the submission on May 13, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K211491 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2021
Decision Date	July 12, 2021
Days to Decision	60 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.