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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K133730
Device Name CO PILOT/REGIUS UNITEA
Applicant
Konica Minolta, Inc.
140 E. 45th St., 25th Floor
Two Grand Tower
New York,  NY  10017
Applicant Contact RUSSELL MUNVES
Correspondent
Konica Minolta, Inc.
140 E. 45th St., 25th Floor
Two Grand Tower
New York,  NY  10017
Correspondent Contact RUSSELL MUNVES
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/06/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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