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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 doppler, ultrasonic
510(k) Number K061946
Device Name ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
p o box 7393
mountain view,  CA  94039 7393
Original Contact sheila w pickering
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/10/2006
Decision Date 07/21/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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