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

Product Code: PZC

Ultrasonic Medical Devices (Miscellaneous)

Definition: An Imaged-guided Focused Ultrasound System Is Intended To Use High Intensity Focused Ultrasound (hifu) To Heat And Ablate Soft Tissue.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsNo

Products Classified as PZC

5965Ablation System, High Intensity Focus Ultrasound (hifu), Soft Tissue

Total Product Life Cycle (TPLC) Devices

5965Ablation System, High Intensity Focus Ultrasound (hifu), Soft Tissue
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