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RefleXion X1 Biology-Guided Radiotherapy Delivery Unit from Mexico

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 — Mexico → United States

11.4%

Rate breakdown

9903.05.5510%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.94, articles the product of Mexico, as provided for in U.S. note 52 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