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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 K121916
Model 4.4
Device Name INTUITION
Original Applicant
TERARECON, INC.
4000 e 3rd ave ste 200
foster city,  CA  94404
Original Contact robert taylor
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/03/2012
Decision Date 04/02/2013
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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