RefleXion X1 Biology-Guided Radiotherapy Delivery Unit from China

RefleXion X1 PET-guided beam delivery unit uses real-time tumor metabolic imaging to dynamically direct radiation beams to moving targets. Integrates PET scanner, linac, and starboard gantry delivery system. HTS 9022.90.1500 for advanced biology-guided radiation beam delivery systems.

Duty Rate — China → United States

36.4%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 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

Include FDA Breakthrough Device Designation documentation and clinical trial data

Provide PET signal-to-dose correlation validation and real-time tracking accuracy reports

Document multi-target delivery sequencing algorithms and collision avoidance verification