Cleared Traditional

K031929 - 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION (FDA 510(k) Clearance)

K031929 · Wide Corporation · Radiology device

Jul 2003

Decision

15d

Days

Class 2

Risk

K031929 is an FDA 510(k) clearance for the 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION. 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 8, 2003, 15 days after receiving the submission on June 23, 2003.

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

Submission Details

510(k) Number	K031929 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 2003
Decision Date	July 08, 2003
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF