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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K121076
Model TUW-U001S
Device Name ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
tustin,  CA  92781 2068
Original Contact charlemagne chua
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
IYL   IYN  
Date Received04/09/2012
Decision Date 10/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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