Cleared Traditional

K032174 - WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A (FDA 510(k) Clearance)

Jul 2003
Decision
8d
Days
Class 2
Risk

K032174 is an FDA 510(k) clearance for the WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Wide Corporation (Denton, US). The FDA issued a Cleared decision on July 24, 2003, 8 days after receiving the submission on July 16, 2003.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

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

Device Classification

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