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RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.

The system functionality can be configured based on user needs.

RayStation consists of multiple applications:

• The main RayStation application is used for treatment planning.
• The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
• The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.

The device to be marketed, RayStation 2024A SP3, adds the RayTreat application compared with last cleared version, the predicate RayStation 2024A SP3 (without RayTreat), K240398.

The RayTreat application was previously cleared with RayStation 11B, K220141. Since then some RayTreat functions have been changed:

• RayTreat is now session focused
• Usability improvements
• Bug fixes

The RayStation applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data.

As a treatment planning system, RayStation aims to be an extensive software toolbox for generating and evaluating various types of radiotherapy treatment plans. RayStation supports a wide variety of radiotherapy treatment techniques and features an extensive range of tools for manual or semi-automatic treatment planning.

The RayStation applications are divided into modules, which are activated through licensing.

The RayTreat application
RayTreat manages treatment delivery. An approved plan can be assigned to fractions in a treatment course and sent to the treatment delivery device. Treatment records from the treatment delivery device are recorded and sent to RayCarePACS.

Note that all real-time monitoring of actual delivery is handled by treatment delivery device software, not by RayStation.

Scientific concepts that form the basis for the device and significant performance characteristics:

RayStation is a stand-alone software medical device intended for radiation therapy. Input to the device is patient, disease and treatment unit information, output from the device is one or more treatment plans. The treatment plans include treatment unit parameter settings for optimal beam arrangements, energies, field sizes, and ultimately fluence patterns to produce as safe and effective radiation dose distribution as the predicate.

The scientific concepts of a treatment planning system are patient and beam modeling, and algorithms for dose calculation and plan parameter optimization.

The patient model is a computerized representation of the patient tissue and densities, identifying the target regions and particular organs at risk. The model is based on medical images of the patient and must have the desired level of accuracy. Likewise, the beam modeling is a computerized representation of the treatment unit, defined by fluence type, energy distribution, machine specific geometry, and beam modifiers such as MLC, flattening filters, wedges etc. The algorithms for dose calculation and plan parameter optimization must take into account all geometries and materials that affect irradiation transport through the treatment unit and the patient. The optimization algorithm iterates treatment plan parameters until the desired treatment plan and dose distribution have been obtained. Also here, all steps must be done to the desired level of accuracy.

Significant physical characteristics of the device, material used, and physical properties:

The device is a standalone software medical device. It has no physical properties or materials. The device design information can be found in the subsection above "Device design information".

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The Rectal Applicator is intended for brachytherapy for treatment of rectal and anal cancer in combination with Elekta HDR and PDR remote controlled afterloaders.

In brachytherapy the first treatment step is to position a brachytherapy applicator in or on the patient in order to reach the target volume. The second step is to determine the desired positions and dwell times of the source within the applicator to encompass the target volumes as good and optimal as possible, creating a treatment plan.

The Rectal Applicator is an applicator for brachytherapy procedures indicated for treatment of rectal and anal cancer. The device is used in hospitals.

The Rectal Applicator has eight channels to guide a radioactive source or another accessory (e.g. check cable or marker) through the channel to a certain position. Transfer Tubes can be connected to the proximal end of the channels. The Transfer Tubes can be connected to Elekta HDR and PDR remote controlled afterloaders (Flexitron HDR/MicoSelectron digital / V2).

The applicator can be inserted free-hand or using the Insertion Tool. The Insertion Tool can be removed after the insertion or can stay in place during the treatment.

After the insertion of the applicator, the Fixation Element can be used for immobilization (using the Applicator clamp). The Fixation Element can be fixated to the applicator using the Fixation Clip.

Parts included in this 510(k):

• Rectal Applicator
• Fixation Element
• Fixation Clip
• Insertion Tool

Rectal Applicator
The Rectal Applicator is a flexible, cylindrical applicator containing eight flexible channels which can be used to optimize the target dose. In case of asymmetric tumors (which is mostly the case), only the needed channels can be loaded. When inserting the applicator under fluoroscopy (e.g., C-arm) in the sagittal or frontal plane, the integrated marker can be used to verify if the applicator has been inserted deep enough to cover the full target volume. The centimeter length markings on the applicator can be used as indications for the insertion depth. The markings can not be used for determining the most distal dwell position.

The Rectal Applicator is a sterile (EO), single use device mainly made of silicone material including an adhesive and silicone ink (centimeter scale). The applicator will come in direct contact with comprised mucosa (max. 24 h). The Rectal Applicator is classified as MR conditional.

Fixation Element and Fixation Clip
The Fixation Element can be placed on the applicator before or after insertion of the applicator. The Fixation Clip fixates the Fixation Element on the applicator and the design of the Fixation Element facilitate the possibility to immobilize the applicator to the CT/MR Applicator Clamp.

The Fixation Element and Clip are made of PPSU white and will come in indirect contact with intact skin (max. 24 h) and are MR Safe.

The Fixation Element and Fixation Clip are reusable and can be reprocessed using cleaning (manual or automated) and moist heat sterilization.

Insertion Tool
The Insertion Tool fits into the center cavity of the applicator and will make the applicator rigid to insert the rectal applicator into the rectum.

The Insertion Tool, made of PPSU white and glass fiber reinforced composite, is considered to be non-body contacting and can be reprocessed using cleaning (manual or automated) and moist heat sterilization.

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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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The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

The Revi System is an implanted tibial electrical urinary continence device that wirelessly receives power from a non-implanted external wearable unit to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of urgency incontinence, alone or in combination with urinary urgency.

The implantable device is implanted in the vicinity of the tibial neurovascular bundle. The treatment effect of the system is achieved by the implantable wireless neurostimulation component, which sends pulses to the tibial nerve when energized by the wearable unit transmitted power. The electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord. This stimulation is theorized to have the power to modulate nerve function, relieving symptoms.

The modifications reported in this 510(k) submission include introducing an updated Wearable Unit, an associated software update to support the updated Wearable Unit and related labeling. These modifications do not affect the implantable component of the Revi System or the indications for use.

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REAL INTELLIGENCE™ CORI™ XT is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:

• unicondylar knee replacement (UKR),
• total knee arthroplasty (TKA),
• revision knee arthroplasty,
• anatomic total shoulder arthroplasty (aTSA), and
• reverse total shoulder arthroplasty (rTSA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI XT (CORI XT), a robotic orthopedic surgical navigation and burring system. Like its predecessor, REAL INTELLIGENCE CORI (K240139), CORI XT uses established technologies of navigation via a passive infrared tracking camera. CORI XT aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI XT intraoperative software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• Exposure control adjusts the bur's exposure with respect to a guard.
• Speed control regulates the signal going to the motor control module.

When the surgeon encroaches on a portion of bone that is not to be cut per the surgeon's plan, the robotic system will disable cutting by retracting the bur inside the guard or by limiting the speed of the drill. Alternatively, the surgeon can disable both cutting controls and operate the robotic drill as a standard navigated surgical drill.

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The Remvia NightGuard is indicated for:
• Protection against teeth grinding, bruxism, and jaw clenching
• Short-term pain relief from muscle spasm due to occlusal interference
• Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The Remvia NightGuard is an intraoral appliance intended to mitigate the harmful effects of nocturnal bruxism. Remvia is retained within the posterior buccal vestibule and retromolar region, using anatomical support from safe, stress-bearing zones. The device does not cover dentition, thereby avoiding continuous occlusal loading and instead creating progressive resistance as clench force increases.

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