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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
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4 Rue F. Pelloutier
Croissy-Beaubourg,  FR 77435
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
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4 Rue F. Pelloutier
Croissy-Beaubourg,  FR 77435
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/18/2011
Decision Date 02/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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