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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 K112997
Device Name HD-IVUS ULTRASOUND IMAGING SYSTEM
Original Applicant
SILICON VALLY MEDICAL INSTRUMENTS, INC.
47697 westinghouse
suite 101
fremont,  CA  94539
Original Contact richard e anderson
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received10/07/2011
Decision Date 12/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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