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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 K122022
Device Name ATHEROEDGE
Original Applicant
ATHEROPOINT LLC
208 otter glen ct
roseville,  CA  95661
Original Contact jasjit s suri
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/10/2012
Decision Date 09/26/2012
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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