VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

Microscope, Automated, Image Analysis, Operator Intervention

VENTANA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Virtuoso System For Ihc Ki-67 (30-9).

Pre-market Notification Details

Device IDK111755
510k NumberK111755
Device Name:VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
ClassificationMicroscope, Automated, Image Analysis, Operator Intervention
Applicant VENTANA MEDICAL SYSTEMS, INC. 1910 E.INNOVATION PARK DR. Tucson,  AZ  85755
ContactTroy Quander
CorrespondentTroy Quander
VENTANA MEDICAL SYSTEMS, INC. 1910 E.INNOVATION PARK DR. Tucson,  AZ  85755
Product CodeNOT  
Subsequent Product CodeNQN
Subsequent Product CodeOEO
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-22
Decision Date2012-02-22
Summary:summary

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