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Medical Betatron Electron Accelerator from China

Betatron for intraoperative radiation therapy accelerating electrons to produce X-rays during surgery. Falls under HTS 8543.10.00.00 as a particle accelerator designed for medical radiation delivery. Compact design for operating room integration.

Duty Rate — China → United States

39.4%

Rate breakdown

9903.05.3112.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of China, as provided for in U.S. note 52 to this subchapter
9903.88.0125%Except as provided in headings 9903.88.05, 9903.88.06, 9903.88.07, 9903.88.08, 9903.88.10, 9903.88.11, 9903.88.14, 9903.88.19, 9903.88.50, 9903.88.52, 9903.88.58, 9903.88.60, 9903.88.62, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(a) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(b) [to this subchapter]

Import Tips

• FDA premarket approval documentation mandatory for medical accelerators

• Sterilization validation and biocompatibility testing records required

• Specify intraoperative use to distinguish from research accelerators