Cleared Traditional

CO PILOT/REGIUS UNITEA

K133730 · Konica Minolta, Inc. · Radiology

Jan 2014

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K133730 is an FDA 510(k) clearance for the CO PILOT/REGIUS UNITEA, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Konica Minolta, Inc. (New York, US). The FDA issued a Cleared decision on January 31, 2014, 56 days after receiving the submission on December 6, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K133730 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2013
Decision Date	January 31, 2014
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF