Cleared Traditional

K090603 - BARCO 5MP MAMMO, MODEL MDMG-5221 (FDA 510(k) Clearance)

K090603 · Barco N.V. · Radiology device

Apr 2009

Decision

48d

Days

Class 2

Risk

K090603 is an FDA 510(k) clearance for the BARCO 5MP MAMMO, MODEL MDMG-5221. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Barco N.V. (Beaverton, US). The FDA issued a Cleared decision on April 22, 2009, 48 days after receiving the submission on March 5, 2009.

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

Submission Details

510(k) Number	K090603 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 2009
Decision Date	April 22, 2009
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement