Cleared Traditional

K131137 - 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) (FDA 510(k) Clearance)

K131137 · Jvckenwood Corporation · Radiology device

Jul 2013

Decision

86d

Days

Class 2

Risk

K131137 is an FDA 510(k) clearance for the 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Jvckenwood Corporation (Nagano-Ken, JP). The FDA issued a Cleared decision on July 18, 2013, 86 days after receiving the submission on April 23, 2013.

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

Submission Details

510(k) Number	K131137 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 23, 2013
Decision Date	July 18, 2013
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF