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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, In.C
2441 Michelle Dr.
Tustin,  CA  92781 -2068
Applicant Contact CHARLEMAGNE CHUA
Correspondent
Toshiba America Medical Systems, In.C
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
Predetermined Change
Control Plan Authorized		 No
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