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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ablation system, high intensity focused ultrasound (hifu), mr-guided
Definition An mr-guided focused ultrasound system is intended to use hifu to ablate soft tissue. Mr imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.
Product CodeNRZ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
2 0 2 2 2 3 5 1 2 0

Device Problems
Material perforation 1
Total Device Problems 1

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