Intended Use

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.

Technology

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

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/23/2024

    1 month
  • 2

    FDA Approval

    11/21/2024

Other devices from Varian Medical Systems, Inc.

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