The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.
Used with radiotherapy delivery systems or respiratory gating and motion management systems to track breathing pattern and other patient motions during treatment or image acquisition.
Passive hardware device consisting of a plastic block with four mounted reflective optical markers that reflect infrared light for tracking by cameras; used as a surrogate for patient respiratory motion by measuring displacement and rotation of the block placed on the skin.
Performance testing included biocompatibility, cleaning validation, usability testing, and formal design verification and validation. The device demonstrates expected performance and meets applicable safety standards. No clinical or animal studies were conducted.
No predicate devices specified
Submission
9/23/2024
FDA Approval
11/21/2024
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