Cleared Traditional

K113784 - 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340

K113784 is an FDA 510(k) clearance for 3MP MONOCHROME LCD MONITOR, manufactured by Eizo Nanao Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K113784 · Eizo Nanao Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
71d
Days
Class 2
Risk

K113784 is an FDA 510(k) clearance for the 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340. 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, JP). The FDA issued a Cleared decision on March 2, 2012 after a review of 71 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: Incremental AI imaging tool. Moderate equivalence dependency. 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 - K113784

510(k) Number K113784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date March 02, 2012
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1926
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K113784.
ORTHOSIZE
K120115 · Orthosize, LLC · Mar 2012
QLAB QUANTIFICATION SOFTWARE
K120525 · Philips Healthcare Group · Mar 2012
SONOVISION
K113082 · Peridot Technologies Ny, Inc. · Mar 2012
X-RAY VVA
K112807 · Medis Medical Imaging Systems BV · Feb 2012
RADIFORCE RX240
K113844 · Eizo Nanao Corporation · Feb 2012
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
K112679 · Materialise Dental NV · Feb 2012