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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 K071000
Device Name MYRIAN
Applicant
Intrasense
Bat B-99, Route D'Espagne
Les Portes D'Espagne
Toulose,  FR 31100
Applicant Contact NICOLAS CLARY
Correspondent
Intrasense
Bat B-99, Route D'Espagne
Les Portes D'Espagne
Toulose,  FR 31100
Correspondent Contact NICOLAS CLARY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/09/2007
Decision Date 05/14/2007
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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