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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 K120115
Device Name ORTHOSIZE
Applicant
ORTHOSIZE LLC
1835 market street, 29th floor
philadelphia,  PA  19103
Contact yarmela pavlovic
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/13/2012
Decision Date 03/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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