Cleared Abbreviated

K233465 - RadiForce MX317W

K233465 is the FDA 510(k) clearance for RadiForce MX317W by Eizo Corporation. It is a Class 2 Radiology device (product code PGY) cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K233465 · Eizo Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
58d
Days
Class 2
Risk

K233465 is an FDA 510(k) clearance for the RadiForce MX317W. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Eizo Corporation (Hakusan, Ishikawa, JP). The FDA issued a Cleared decision on December 21, 2023 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight 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 K233465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2023
Decision Date December 21, 2023
Days to Decision 58 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - 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.
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 Radiology devices follow this clearance model.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 82
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K233465.
LCD Monitors C310S, G310S, C316S, G316S, C616W
K240310 · Shenzhen Beacon Display Technology Co., Ltd. · Mar 2024
Medical Monitor (21HQ613D)
K240130 · Lg Electronics.Inc · Feb 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
K233897 · Shenzhen Beacon Display Technology Co., Ltd. · Feb 2024
24HR513C
K232985 · Lg Electronics.Inc · Dec 2023
Nio Color 8MP (MDNC-8132)
K233693 · Barco N.V. · Dec 2023
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
K231026 · Shenzhen Beacon Display Technology Co., Ltd. · Aug 2023