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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 K123622
Model SC2000
Device Name ACUSON
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
685 east middlefield road
mountain view,  CA  94043 0000
Original Contact patrick lynch
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received11/23/2012
Decision Date 12/05/2012
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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