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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)
2018 2019 2020 2021 2022 2023
3 0 0 0 0 0

MDR Year MDR Reports MDR Events
2019 3 3
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 3 3
Burn(s) 2 2
Partial thickness (Second Degree) Burn 1 1
Peripheral Nervous Injury 1 1

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