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The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician-approved plan.

The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan.

For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under "FDG Medical Imaging Agent Information".

The RefleXion X2 System is a hybrid imaging and treatment platform designed to deliver multiple forms of external beam radiation therapy, including Intensity-Modulated Radiation Therapy (IMRT), Stereotactic Body Radiation therapy (SBRT), Stereotactic Radiotherapy (SRT), Stereotactic Radiosurgery (SRS), and biology-guided radiotherapy (BgRT).

The subject device (X2 System) is based on the same fundamental design as the X1 System (predicate device, DEN220014). Both systems integrate radiation delivery, imaging (CT and PET), and treatment planning capabilities into a single device.

• 6 MV photon radiotherapy delivery
• Positron Emission Tomography (PET) imaging
• Kilovoltage (kV) X-ray CT imaging
• Treatment planning

The radiation delivery subsystem includes a LINAC mounted within the therapy plane, utilizing a fixed primary collimator, adjustable upper and lower jaws, and a multileaf collimator (MLC) to shape and modulate the treatment beam. PET detector arcs are also mounted within the therapy plane to detect emissions from radiotracers during treatment, enabling biology-guided radiotherapy (BgRT). The kVCT imaging subsystem operates in a separate imaging plane and provides anatomical imaging for patient setup and verification prior to treatment delivery.

The X2 System incorporates several design updates relative to the X1 System, including enhancements to the PET subsystem, updates to kVCT components, hardware improvements aimed at manufacturing reliability and serviceability, software infrastructure upgrades, usability enhancements such as intrafraction PET image viewing and multi-target treatment workflows, and cybersecurity improvements. These changes do not alter the device's intended use, fundamental scientific technology, or safety and effectiveness.

No new patient-contacting materials, contamination pathways, or reprocessing requirements have been introduced. Consequently, the risk profile of the device, including the risk of infection or other adverse events, remains unchanged from the predicate device.

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