Cleared Traditional

K172738 - RadiForce RX560, RX560-AR

K172738 is an FDA 510(k) clearance for RadiForce RX560, manufactured by Eizo Corporation. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K172738 · Eizo Corporation · Radiology device
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Nov 2017
Decision
57d
Days
Class 2
Risk

K172738 is an FDA 510(k) clearance for the RadiForce RX560, RX560-AR. 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 November 8, 2017 after a review of 57 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eizo Corporation devices

FDA 510(k) Submission Details - K172738

510(k) Number K172738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date November 08, 2017
Days to Decision 57 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K172738.
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