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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, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
510(k) Number K073677
Device Name SCANSCOPE XT SYSTEM
Applicant
Aperio Technologies
1430 Vantage Court, Suite 106
Vista,  CA  92081
Applicant Contact JEFF RYBERG
Correspondent
Aperio Technologies
1430 Vantage Court, Suite 106
Vista,  CA  92081
Correspondent Contact JEFF RYBERG
Regulation Number864.1860
Classification Product Code
NQN  
Date Received12/28/2007
Decision Date 08/01/2008
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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