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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%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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