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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K063085
Device Name MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P O Box 7393
Mountain View,  CA  94039 -7393
Applicant Contact SHEILA W PICKERING
Correspondent
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P O Box 7393
Mountain View,  CA  94039 -7393
Correspondent Contact SHEILA W PICKERING
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DQO   ITX   IYN  
Date Received10/10/2006
Decision Date 11/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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