Cleared Abbreviated

K180961 - RadiForce MX194

K180961 is an FDA 510(k) clearance for RadiForce MX194, manufactured by Eizo Corporation. The device is a Class 2 Radiology device with product code PGY cleared through the Abbreviated 510(k) pathway after a 28-day FDA review.

K180961 · Eizo Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
28d
Days
Class 2
Risk

K180961 is an FDA 510(k) clearance for the RadiForce MX194. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on May 10, 2018 after a review of 28 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

FDA 510(k) Submission Details - K180961

510(k) Number K180961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2018
Decision Date May 10, 2018
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Standards-based clearance path.

PGY Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K180961.
RadiForce RX360, RX360-AR
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K172815 · Shenzhen Beacon Display Technology Co., Ltd. · Oct 2017