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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 K121646
Device Name ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
685 east middlefield road
mountain view,  CA  94043
Original Contact shelly pearce
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/05/2012
Decision Date 06/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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