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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

MapRT is used by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation. MapRT uses two lateral wide-field cameras in simulation to deliver a full 3D model of patients and accessories. This model is then used to calculate a clearance map for every couch (x-axis) and gantry (y-axis) angles. Radiotherapy treatment plans can then be imported automatically to check beams, arcs, and the transition clearance.

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 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 (K212583) is a combination of the devices AlignRT InBore, AlignRT Offline, 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 pation 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 pation will, however, project a pattern on the patient to acquire a 3D image of the patient. This 510(k) notification is to obtain clearance for the following changes to the cleared device: - 1. Introduction of new software, version 7.3. This is an updated version of the existing cleared software, to support the: - a. New Cherenkov imaging feature, called DoseRT. - b. Updated respiratory gating feature, called Respiratory Module. - 2. Introduction of new hardware: - a. DoseRT camera to enable Cherenkov imaging. - 3. Update to indications for use to include the new Cherenkov imaging feature and clarify existing indications.

MapRT is indicated for assisting with planning of radiation therapy by: - Assessing which combinations of ganty/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.

The MapRT module is intended for use by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation. MapRT is a system which uses advanced software and couch markers to deliver a full 3D model of the patient and accessories. This model is used to calculate a clearance map for all couch and gantry angles. Plans can be imported to check beams, arcs and transition clearance.

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

The AlignRT Plus system (K203387) is a combination of the devices AlignRT, GateCT and GateRT. AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process. AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals. Real-time imaging and surface matchinq of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances. Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals. AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position. Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module". The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT. This 510(k) is requested for a modifications to FDA 510(k) cleared product "AlignRT Plus" (K203387). This 510(k) is to obtain clearance for the following changes to the cleared device: - Introduction of new software, SimRT 7.2. This is an updated version of the cleared software, GateCT, with a new user interface similar to the cleared AlignRT 6.2/6.3/6.4 software; - 2. Introduction of new camera pods (hardware). These function in the same way as the currently cleared hardware but are aesthetically different and have upgraded capabilities to support future product development; - 3. Improve the product's accuracy claim for Source-Surface Distancing (SSD) from <2.0mm to <0.2mm.

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

The AlignRT Plus system (K193431) is a combination of the devices AlignRT, GateCT and GateRT. A special 510(K) K193431 was submitted by Vision RT Ltd. in December 2019 and this was cleared by FDA in January 2020 for the changes and improvements made in AlignRT. AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process. AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals. Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances. Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals. AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position. Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module". The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT. This 510(k) is requested for a new optional InBore camera and a change in memory size for an existing FDA 510(k) cleared product "AlignRT Plus" (K193431). The InBore camera is optional hardware for use with bore-based linear accelerators. The increase in memory size from 32 to 64bit increases the system's processing speed, enabling a frame rate improvement.

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is noninvasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process. AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals. Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances. Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals. AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position. Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module". The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT. This Special 510(k) is requested only for software modification for an existing 510(k) cleared product "AlignRT Plus" (K181218). No hardware or material changes have been made since its last 510(k) clearance. The two key changes made in the existing AlignRT v6.0 software which are the subject of this Special 510(k) are listed below; 1. System Frame Rate improvement 2. Addition of Video Postural Setup Alignment feature

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

The AlignRT Plus system (K123371) is a combination of the devices AlignRT, GateCT and GateRT. It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is noninvasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process. AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals. Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances. Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals. AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position. Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module". The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.