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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
Device Name ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
TUSTIN,  CA  92781 -2068
Applicant Contact CHARLEMAGNE CHUA
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
TUSTIN,  CA  92781 -2068
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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