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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 K080211
Device Name MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin,  CA  92781 -2068
Original Contact paul biggins
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/29/2008
Decision Date 03/14/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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