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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 K120207
Device Name VISIA
Applicant
Mevis Medical Solutions AG
N27 W24075 Paul Court
Suite 100
Pewaukee,  WI  53072
Applicant Contact THOMAS E TYNES
Correspondent
Mevis Medical Solutions AG
N27 W24075 Paul Court
Suite 100
Pewaukee,  WI  53072
Correspondent Contact THOMAS E TYNES
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/24/2012
Decision Date 04/23/2012
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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