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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Automated, Image Analysis, Operator Intervention
510(k) Number K121350
Device Name VIRTUSO SYSTEM FOR IHC (DO-7)
Applicant
Ventana Medical Systems, Inc.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Applicant Contact ERIKA AMMIRATI
Correspondent
Ventana Medical Systems, Inc.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact ERIKA AMMIRATI
Regulation Number864.1860
Classification Product Code
NOT  
Subsequent Product Codes
NQN   OEO  
Date Received05/04/2012
Decision Date 06/01/2012
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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