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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K151048
Device Name CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
Applicant
Bracco Injeneering
Ave. De Sevelin 46
Lausanne,  CH CH-1004
Applicant Contact MAUD GIORGI
Correspondent
Icon Clinical Research, LLC
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact CYNTHIA NOLTE
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received04/20/2015
Decision Date 01/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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