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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 K113541
Device Name CLEARSTART SVM SYSTEM
Applicant
INTIO INC.
325 interlocken parkway
broomfield,  CO  80021
Contact david gustafson
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/01/2011
Decision Date 12/16/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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