VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS

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, Model Vias.

Pre-market Notification Details

Device IDK062428
510k NumberK062428
Device Name:VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
ClassificationMicroscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Applicant TRIPATH IMAGING, INC. 4025 STIRRUP CREEK DRIVE STE. 400 Durham,  NC  27703
ContactBryan J Tucker
CorrespondentBryan J Tucker
TRIPATH IMAGING, INC. 4025 STIRRUP CREEK DRIVE STE. 400 Durham,  NC  27703
Product CodeNQN  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-18
Decision Date2006-09-29

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