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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Automated, Image Analysis, Operator Intervention
510(k) Number K062756
Device Name PATHIAM IMAGING SOFTWARE FOR HER2/NEU
Applicant
Bioimagene, Inc.
1601 S. De Anza Blvd.
Cupertino,  CA  95014
Applicant Contact ANNA LONGWELL
Correspondent
Bioimagene, Inc.
1601 S. De Anza Blvd.
Cupertino,  CA  95014
Correspondent Contact ANNA LONGWELL
Regulation Number864.1860
Classification Product Code
NOT  
Date Received09/14/2006
Decision Date 02/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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