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U.S. Department of Health and Human Services

Product Classification

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Device ablation system, high intensity focus ultrasound (hifu), soft tissue
Definition An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.
Physical State Transducer Array, Computer Workstation, Water Chiller, Image Table.
Technical Method An Imaged-Guided Focused Ultrasound System is intended to Device uses high frequency ultrasound to heat and ablate soft tissue.
Target Area Soft Tissue.
Review Panel General & Plastic Surgery
Product CodePZC
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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