VENTANA IMAGE ANALYSIS SYSTEM

Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

TRIPATH IMAGING, INC.

The following data is part of a premarket notification filed by Tripath Imaging, Inc. with the FDA for Ventana Image Analysis System.

Pre-market Notification Details

Device IDK050012
510k NumberK050012
Device Name:VENTANA IMAGE ANALYSIS SYSTEM
ClassificationMicroscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Applicant TRIPATH IMAGING, INC. 780 PLANTATION DR. Burlington,  NC  27215
ContactBryan Tucker
CorrespondentBryan Tucker
TRIPATH IMAGING, INC. 780 PLANTATION DR. Burlington,  NC  27215
Product CodeNQN  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-03
Decision Date2005-05-06

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