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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 K121553
Model TSX-101A/R
Device Name AQUILION RXL
Original Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin,  CA  92780
Original Contact paul biggins
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/25/2012
Decision Date 07/26/2012
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
Recalls CDRH Recalls
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