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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 K103565
Device Name MEDVOXEL HEARTPRO SOFTWARE APPLICATION
Applicant
Medvoxel Systems, Inc.
2867 Crosscurrent Dr.
Mississauga,  CA L5N6L1
Applicant Contact BONNIE SEWLOCHAN
Correspondent
Medvoxel Systems, Inc.
2867 Crosscurrent Dr.
Mississauga,  CA L5N6L1
Correspondent Contact BONNIE SEWLOCHAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/06/2010
Decision Date 04/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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