Cleared Abbreviated

K241441 - RadiForce RX670

Also marketed or referenced as:
RadiForce RX670-AR

K241441 is the FDA 510(k) clearance for RadiForce RX670 by Eizo Corporation. It is a Class 2 Radiology device (product code PGY) cleared through the Abbreviated 510(k) pathway after a 55-day FDA review.

K241441 · Eizo Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
55d
Days
Class 2
Risk

K241441 is an FDA 510(k) clearance for the RadiForce RX670. 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 July 16, 2024 after a review of 55 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 K241441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2024
Decision Date July 16, 2024
Days to Decision 55 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
52d faster than avg
Panel avg: 107d · This submission: 55d
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
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