Cleared Abbreviated

K242545 - RadiForce MX317W-PA (FDA 510(k) Clearance)

Class II Pathology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K242545 · Eizo Corporation · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
269d
Days
Class 2
Risk

K242545 is an FDA 510(k) clearance for the RadiForce MX317W-PA. Classified as Digital Pathology Display (product code PZZ), Class II - Special Controls.

Submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on May 23, 2025 after a review of 269 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Eizo Corporation devices

Submission Details

510(k) Number K242545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 77d · This submission: 269d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PZZ Digital Pathology Display
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.