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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 K093891
Device Name AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
Applicant
Toshibamedical Systems Corporation
2441 Michelle Dr.
Tustin,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
Toshibamedical Systems Corporation
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/18/2009
Decision Date 11/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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