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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 K113419
Device Name CS IMAGING
Applicant
TROPHY
4 rue f. pelloutier
croissy-beaubourg, 
Contact marie-pierre labat-camy
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/18/2011
Decision Date 02/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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