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Mr-Guided Focused Ultrasound System

Mr-Guided Focused Ultrasound System 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
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Mr-Guided Focused Ultrasound System
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

POH

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Class 3

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure.