Cleared Traditional

K153354 - 3MP Color LCD Monitor, RadiForce RX350

K153354 is an FDA 510(k) clearance for 3MP Color LCD Monitor, 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 53-day FDA review.

K153354 · Eizo Corporation · Radiology device
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Jan 2016
Decision
53d
Days
Class 2
Risk

K153354 is an FDA 510(k) clearance for the 3MP Color LCD Monitor, RadiForce RX350. 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 January 12, 2016 after a review of 53 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 - K153354

510(k) Number K153354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date January 12, 2016
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
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 K153354.
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
K160328 · The Linden Group Corp · Feb 2016
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K160247 · Eizo Corporation · Feb 2016
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
K160326 · Jvckenwood Corporation · Feb 2016
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
K152713 · Eizo Corporation · Nov 2015
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
K152847 · Qubyx , Ltd. · Nov 2015
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
K152030 · Qingdao Hisense Medical Equipment Co., Ltd. · Sep 2015