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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 K111102
Device Name RADIOVISION
Original Applicant
HAAS SOFTWARE
38 miller avenue pmb 170
mill valley,  CA  94941
Original Contact david l stark
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/20/2011
Decision Date 05/05/2011
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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