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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K120710
Model TSX-302A/2
Device Name AQUILION PRIME
Original Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin,  CA  92780
Original Contact paul biggins
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
ITX   IYO  
Date Received03/08/2012
Decision Date 04/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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