PATHIAM IMAGING SOFTWARE FOR HER2/NEU

Microscope, Automated, Image Analysis, Operator Intervention

BIOIMAGENE, INC.

The following data is part of a premarket notification filed by Bioimagene, Inc. with the FDA for Pathiam Imaging Software For Her2/neu.

Pre-market Notification Details

Device IDK062756
510k NumberK062756
Device Name:PATHIAM IMAGING SOFTWARE FOR HER2/NEU
ClassificationMicroscope, Automated, Image Analysis, Operator Intervention
Applicant BIOIMAGENE, INC. 1601 S. DE ANZA BLVD Cupertino,  CA  95014
ContactAnna Longwell
CorrespondentAnna Longwell
BIOIMAGENE, INC. 1601 S. DE ANZA BLVD Cupertino,  CA  95014
Product CodeNOT  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-14
Decision Date2007-02-20
Summary:summary

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