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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 K033418
Device Name TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
P.O. Box 2068
Tustin,  CA  92781 -2068
Applicant Contact PAUL BIGGINS
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/27/2003
Decision Date 11/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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