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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Digital Image Manual Interpretation Microscope
510(k) Number K142965
Device Name Virtuoso System for IHC PR (1E2) using iScan HT
Applicant
Ventana Medical Systems, Inc.
203 Ravendale Dr.
Mountain View,  CA  94043
Applicant Contact Morteza Minaee
Correspondent
Ventana Medical Systems, Inc.
203 Ravendale Dr.
Mountain View,  CA  94043
Correspondent Contact Yassine Labiad
Regulation Number864.1860
Classification Product Code
OEO  
Date Received10/14/2014
Decision Date 07/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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