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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 K102000
Device Name IMAGYS
Applicant
Keosys Sas
Impasse Augustin Fresnel,
Z.A. Du Moulin Neuf B.P. 227
Saint-Herblain,  FR 44815
Applicant Contact ANTHONY MOTTIER
Correspondent
Keosys Sas
Impasse Augustin Fresnel,
Z.A. Du Moulin Neuf B.P. 227
Saint-Herblain,  FR 44815
Correspondent Contact ANTHONY MOTTIER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/15/2010
Decision Date 10/12/2010
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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