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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 K113466
Device Name AQUILION ONE
Applicant
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 MICHELLE DR
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/22/2011
Decision Date 04/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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