Cleared Traditional

K032174 - WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A

K032174 is the FDA 510(k) clearance for WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A by Wide Corporation. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K032174 · Wide Corporation · Radiology device
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Jul 2003
Decision
8d
Days
Class 2
Risk

K032174 is an FDA 510(k) clearance for the WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A. 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 Wide Corporation (Denton, US). The FDA issued a Cleared decision on July 24, 2003 after a review of 8 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 Wide Corporation devices

Submission Details

510(k) Number K032174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2003
Decision Date July 24, 2003
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K032174.
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · Vital Images, Inc. · Oct 2003
HOLOGIC DR IMAGEPRO
K032546 · Hologic, Inc. · Oct 2003
LCD MONITOR, RADIFORCE G11, G31, G51
K032026 · Eizo Nanao Corporation · Aug 2003
PHILIPS VIEWFORUM 2003
K032096 · Philips Medical Systems · Jul 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
K030781 · Eastman Kodak Company · May 2003
20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
K030347 · Eizo Nanao Corporation · May 2003