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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Digital Image Manual Interpretation Microscope
510(k) Number K071671
Device Name SCANSCOPE XT SYSTEM
Applicant
Aperio Technologies
1430 Vantage Court, Suite 106
Vista,  CA  92081
Applicant Contact PERRY JOHNSTON
Correspondent
Aperio Technologies
1430 Vantage Court, Suite 106
Vista,  CA  92081
Correspondent Contact PERRY JOHNSTON
Regulation Number864.1860
Classification Product Code
OEO  
Date Received06/19/2007
Decision Date 12/28/2007
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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