SGN

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Device class

Class II (moderate risk)

Regulation

21 CFR 882.4420

Medical specialty

Neurology

FDA definition

A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling.

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