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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 K122109
Device Name AQUILION ONE VISION, V4.90
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/17/2012
Decision Date 09/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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