Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.
US Regulatory Classifications
Device Characteristics
No
No
No
Not Eligible
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.
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