RefleXion X1 Biology-Guided Radiotherapy Delivery Unit from Japan
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 — Japan → United States
12.5%
Rate breakdown
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, 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