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Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue

Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue 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.

Global Registration Data
Multi-Country Intelligence
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PZC

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Class N

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.