Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, based in Beijing and Shandong.
- Beijing Beautemax Technology Limited Beijing, contract manufacturer
- Beijing Spiritlaser Science & Technology Co., Ltd. Beijing, contract manufacturer
- Beijing Winkonlaser Technology Limited Beijing, contract manufacturer
- Shandong Moonlight Electronics Tech Co., Ltd. Shandong
What Is This Device?
An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.
What Is FDA Product Code PZC?
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue is FDA product code PZC, not classified.
How Does It Reach the US Market?
The FDA sets no standard submission type for this code and asks the applicant to contact its device evaluation office about the route.
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