Cleared Traditional

K052312 - WIDE 5MP (MAMMO) LCD MONITOR SYSTEM (FDA 510(k) Clearance)

K052312 · Wide Corporation · Radiology device

Oct 2005

Decision

44d

Days

Class 2

Risk

K052312 is an FDA 510(k) clearance for the WIDE 5MP (MAMMO) LCD MONITOR SYSTEM. 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 October 7, 2005, 44 days after receiving the submission on August 24, 2005.

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

Submission Details

510(k) Number	K052312 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 24, 2005
Decision Date	October 07, 2005
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF