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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 K113620
Device Name MYRIAN 1.11
Applicant
Intrasense
1231 Ave. Du Mondial 98
Montpellier,  FR 34000
Applicant Contact FREDERIC BANEGAS
Correspondent
Intrasense
1231 Ave. Du Mondial 98
Montpellier,  FR 34000
Correspondent Contact FREDERIC BANEGAS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/07/2011
Decision Date 07/12/2012
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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