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510(k) K111869

VIRTUOSO SYSTEM FOR IHC PR (IE2) by Ventana Medical Systems, Inc. — Product Code NQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2012
Date Received
July 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

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