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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K111161
Device Name PERFSCAPE V2.0
Applicant
Olea Medical
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact KRISTI GUSMAN
Correspondent
Olea Medical
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact KRISTI GUSMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/25/2011
Decision Date 11/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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