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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 K112726
Model SONIX
Device Name SONIX ULTRASOUND SCANNER
Original Applicant
ULTRASONIX MEDICAL CORPORATION
130-4311 viking way
richmond, british columbia,  CA v6v 2k9
Original Contact chas yu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/20/2011
Decision Date 09/27/2011
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
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