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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 K072676
Device Name ACUSON X300 ULTRASOUND SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view,  CA  94039 7393
Original Contact martina vogt
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DQO   ITX   IYN  
Date Received09/24/2007
Decision Date 12/18/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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