Cleared Traditional

K133511 - 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) (FDA 510(k) Clearance)

K133511 · Jvckenwood Corporation · Radiology device

Dec 2013

Decision

35d

Days

Class 2

Risk

K133511 is an FDA 510(k) clearance for the 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025). 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 19, 2013, 35 days after receiving the submission on November 14, 2013.

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

Submission Details

510(k) Number	K133511 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 14, 2013
Decision Date	December 19, 2013
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF