Cleared Special

K060845 - MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310

K060845 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 28-day FDA review.

K060845 · Eizo Nanao Corporation · Radiology device
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Apr 2006
Decision
28d
Days
Class 2
Risk

K060845 is an FDA 510(k) clearance for the MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310. 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 (Hakusan, Ishikawa-Ken, JP). The FDA issued a Cleared decision on April 25, 2006 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. 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 - K060845

510(k) Number K060845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2006
Decision Date April 25, 2006
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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

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