Cleared Traditional

K133185 - 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) (FDA 510(k) Clearance)

K133185 · Jvckenwood Corporation · Radiology device

Dec 2013

Decision

47d

Days

Class 2

Risk

K133185 is an FDA 510(k) clearance for the 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Jvckenwood Corporation (Yokohama-Shi, Kanagawa, JP). The FDA issued a Cleared decision on December 3, 2013, 47 days after receiving the submission on October 17, 2013.

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

Submission Details

510(k) Number	K133185 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 17, 2013
Decision Date	December 03, 2013
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF