Cleared Abbreviated

RadiForce MX317W-PA

K242545 · Eizo Corporation · Pathology
May 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K242545 is an FDA 510(k) clearance for the RadiForce MX317W-PA, a Digital Pathology Display (Class II — Special Controls, product code PZZ), submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on May 23, 2025, 269 days after receiving the submission on August 27, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number K242545 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2024
Decision Date May 23, 2025
Days to Decision 269 days
Submission Type Abbreviated
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code PZZ — Digital Pathology Display
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Digital Pathology Display Device Is Intended For In Vitro Diagnostic Use To Display Digital Images Of Histopathology Slides Acquired From Fda-cleared Whole-slide Imaging Scanners That Are Used For Review And Interpretation By Trained Pathologists.