Intended Use

MapRT is indicated for assisting with planning of radiation therapy by assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.

Technology

MapRT uses two lateral wide-field cameras to deliver a full 3D model of patients and accessories from CT simulation data and calculates a clearance map for every couch and gantry angle. It includes modeling of equipment movement and geometry using LiDAR scans or 3D CAD models, and provides a graphical user interface to visualize collision risk and dose optimization.

Performance

No clinical investigations were performed. Verification and validation testing using summative evaluation techniques were conducted, demonstrating that MapRT works as intended and meets design specifications. Testing passed all required criteria ensuring safety and effectiveness.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/18/2024

    7 months
  • 2

    FDA Approval

    5/19/2025

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