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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 K160334
Device Name Advanced Medical Imaging Software Suite (KSWVWR)
Applicant
Keosys Sas
13 Impasse Serge Reggiani
Saint Herblain,  FR 44815
Applicant Contact Laurence BOY-MACHEFER
Correspondent
Keosys Sas
13 Impasse Serge Reggiani
Saint Herblain,  FR 44815
Correspondent Contact Laurence BOY-MACHEFER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/08/2016
Decision Date 06/21/2016
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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