Cleared Special

K052337 - MONOCHROME LCD MONITOR, MODEL RADIFORCE G33

K052337 is an FDA 510(k) clearance for MONOCHROME LCD MONITOR, manufactured by Eizo Nanao Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 13-day FDA review.

K052337 · Eizo Nanao Corporation · Radiology device
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Sep 2005
Decision
13d
Days
Class 2
Risk

K052337 is an FDA 510(k) clearance for the MONOCHROME LCD MONITOR, MODEL RADIFORCE G33. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Eizo Nanao Corporation (Ishikawa-Ken, JP). The FDA issued a Cleared decision on September 8, 2005 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Eizo Nanao Corporation devices

FDA 510(k) Submission Details - K052337

510(k) Number K052337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date September 08, 2005
Days to Decision 13 days
Submission Type Special
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
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1899
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052337.
CORONIS 2MP-21 AND MFGD 2621
K052403 · Barcoview · Sep 2005
CORONIS 3MP-21 AND MFGD 3621
K052429 · Barcoview · Sep 2005
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C
K052344 · Eizo Nanao Corporation · Sep 2005
AIDA COMPACT II SYSTEM
K052159 · KARL STORZ Endoscopy-America, Inc. · Sep 2005
CARDIOSTREAM SONOAIM
K051853 · Cardiostream, LLC · Aug 2005
NIO 3MP-21
K051901 · Barcoview · Aug 2005