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510(k) Data Aggregation
(180 days)
The AlignRT Plus system is indicated for:
- Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
- Verification of patient identity for their radiation treatment session.
- Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter.
- Withholding the beam automatically during radiation delivery, as well as gating the beam based on the patient's respiratory motion.
- Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
- Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
- Passing and receiving information to/from other systems associated with the radiotherapy treatment.
The AlignRT Plus system (K233622) is a combination of the devices AlignRT, AlignRT InBore, AlignRT Offline, AlignRT PDW, DoseRT, GateCT, GateRT and SimRT.
AlignRT Plus is a video-based three-dimensional (3D) surface imaging system used to monitor the patient's position in 3D before and during radiotherapy treatment. During each treatment session the patient's position is compared to the reference surface and offsets are displayed to the user. The system can be used to track patients' motion during tumour localization in the CT scanner in order to facilitate subsequent 4D CT reconstruction. The system can be used to track the breath hold level consistency throughout the simulation process. The system can also be used to track patient motion during treatment delivery for radiation therapy procedures and hold the beam when the patient is not in position. Use of optional accessories allows the user to:
- monitor the patient's position inside bore-based linacs; and/or
- to view the Cherenkov light emitted by the radiation beam as it enters and exits the patient's skin; and/or
- verify the patient's identity.
The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. The system mainly consists of advanced software, 3D cameras (≤6 cameras) and calibration tools. Each camera pod monitoring the patient's position will, however, project a pattern on the patient to acquire a 3D image of the patient.
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