High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Medical specialty
Neurology
Device class
2
Regulation number
882.4420
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.