Cleared Special

K041597 - MONOCHROME LCD MONITOR

K041597 is the FDA 510(k) clearance for MONOCHROME LCD MONITOR by Eizo Nanao Corporation. It is a Class 2 Radiology device (product code LLZ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K041597 · Eizo Nanao Corporation · Radiology device
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Jun 2004
Decision
30d
Days
Class 2
Risk

K041597 is an FDA 510(k) clearance for the MONOCHROME LCD MONITOR, MODEL RADIFORCE G22. 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 June 24, 2004 after a review of 30 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

Submission Details

510(k) Number K041597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date June 24, 2004
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K041597.
PATXFER RT
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21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)
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SIMPLANT SYSTEM
K033849 · Materialise NV · May 2004