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The ImagingRing m is a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m provides an interface that can be used by system integrators for integration of the ImagingRing m with image guidance systems such as surgical navigation systems.

The ImagingRing m (Version 2.0) is from a technical point of view the same system as its already approved predecessor ImagingRing m (K203281). The only difference is the implementation of a new x-ray source in combination with a software upgrade, which allows for higher power settings. The ImagingRing m functions as a mobile x-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony anatomy and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The ImagingRing m (Version 2.0) provides an interface that can be used by system integration of the ImagingRing m (Version 2.0) with image guidance systems such as surgical navigation systems. The ImagingRing m (Version 2.0) consists of the ring gantry and respective arms carrying the X-Ray source and directly integrates all necessary electronic and components along with low-level software to realize coordinated motion and X-ray emission in the device's ring carrier and legs. The ImagingRing m (Version 2.0) device also provides a detachable Remote Control Panel (RCP) component that provides a display and controls elements such that users can interact with the machine.

The IRm is a mobile X-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required. The IRm provides an interface that can be used by system integration of the IRm with image guidance systems such as surgical navigation systems.

The Mobile ImagingRing System (IRm, "Loop-X" or "Loop-X mobile Imaging Robot") is a robotic, digital X-ray system which supports both 2D planar and fluoroscopic X-ray and 3D Cone-Beam Computed Tomography (CBCT) image acquisition and reconstruction of a patient's anatomical regions of interest (ROI). The design of the Mobile ImagingRing is based on a ring-gantry ("ring") with two arms mounted: the first arm on gantry carries a monoblock X-ray source and a collimator, the second holds a flat-panel detector. The two arms are independently moveable to accommodate individual patient setups and off-center imaging of regions of interest. The ImagingRing m / Loop-X Imaging Robot is intended for mobile use on patients in general and interventional radiology, in sterile and non-sterile areas. The system can be used for diagnostic and interventional purposes by volumetric or planar X-ray imaging and enables image-quided maneuvers and operations in medical fields such as general surgery. traumatology, orthopedics, neurology or radiotherapy. The system is designed for flexible examinations and treatments with patients lying, sitting or standing, with and without contrast agent. It can also be combined with therapy devices such as linear accelerators, particle beam delivery systems or other irradiation devices with active sources and patient positioning systems in Image Guided Radiation Therapy, Intraoperative Radiation Therapy, Brachytherapy or surqical navigation and assistance systems as well as in combination with surgical robots in lmage Guided Surgery, in which the image data provided by the ImagingRing IRm / Loop-X m can be used directly with patient in situ to control the respective therapy maneuvers. Using additional equipment, such as external tracking cameras or the built-in optical cameras, the position of objects such as tracked surgical instruments or pointer tools, for example, can also be determined in the imaging coordinate system. This position data, in combination with the patient's pre- and intra-interventional imaging data, can be used in guided or navigated workflows. The internal cameras of the IRm can also be used to capture pictures and film sequences of the medical procedures.

The ImagingRing System on rails (IRr) is an X-ray device consisting of imaging components, supports and software, designed to support patient localization and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRr facilitates patient localization by means of inaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents. IRr provides 2D planar imaging (including recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, support pationing, monitoring and management of internal target motion, and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement. With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, the IRr is intended to be embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) - receiving commands and data from and providing information to these party systems (e.g., receiving command from RTCS to start an image acquisition and providing image data. providing input for third party RTCS for repositioning of the patient).

This Traditional 510(k) describes modifications made to the medPhoton ImagingRing System. The kev differences are: - In contrast to the existing ImagingRing System. where the ring (imager gantry) is mounted ● on the patient table, in the current system, the ring is mounted on a ceiling-mounted rail which allows longitudinal movement of the ring. - Thus, the ImagingRing System on Rails does not include the patient table. ● - The diameter of the gantry (ring structure carrying the imaging components X-ray generator ● and flat-panel detector) has been increased, providing bigger gantry clearance. This is facilitating positioning of the patient relative to the ImagingRing System on Rails using a Patient Positioning System (PPS) that is provided and controlled by a system integrator since not part of the ImagingRing System on Rails. - A new control console, being used as human machine interface, has been developed to ● improve usability and to simplify imaging workflows (Control Console 2.0). - In addition to the existing basic and slightly extended software (ImagingRing Software ● Suite), front-end software (medPhoton controls) was added to simplify imaging workflows and integration with overall radiation therapy workflow software that is provided and controlled by a svstem integrator. The remaining characteristics and the basic technology have remained the same. The same essential components (X-ray generator and -detector, control system, etc.) are used. Similar to the ImagingRing System, the ImagingRing System on Rails (Rr) is an X-ray imager that is intended to be integrated into a radiation therapy treatment system (e.g. a proton therapy system with its subsystems and workflows) by a system integrator. A major reason for the further development of the ImagingRing System has been to provide a simpler X-ray imager integration option for system integrators. The medPhoton ImagingRing System on Rails (IRr) is an imaging system designed to obtain Two-Dimensional (2D) and Three-Dimensional (3D) X-ray images. The images visualize patient's anatomy whose information can be used to accurately position or re-position the patient undergoing radiotherapy treatment. The IRr consists of - . hardware called ImagingRing (IR) consisting of rails for longitudinal movement, ring gantry, flat-panel detector, X-ray source, generator, control cabinet, control console; - software comprising the ImagingRing Software Suite (ImRiSS) and the medPhoton ● Controls (mPc) to orchestrate image acquisition and data processing; - programmable logic controller (PLC) components and related software (ImagingRing ● Control System - ImRiCS), to execute and control motion and image acquisition.

The ImagingRing System (IRS) is an X-rav device consisting of (1) imaging components, supports and (2) patient support structure (couch top), designed to support patient localization in the Couch Coordinate System (CCS) and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRS facilitates patient localization by means of imaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents. IRS provides 2D planar imaging (including streaming and recording sequences of 2D frames for motion and 3D volumetric imaging before, during and after irradiation, and is intended to support pationing, monitoring and management of internal target motion, and decision making as a function, size, shape and displacement resulting from patient set-up deviation. organ deformation and anatomical movement. With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, IRS is intended to be: · embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) in order to receive commands and data from and provide information to (e.g., receiving command from RTCS to start an image acquisition and providing image data to RTCS for the purpose to calculate and execute the patient (re)-positioning vector externally in the third party system) · interfaced with a Patient Positioning Systems (PPS), like - but not limited to - a robotic multi-axis system, to allow the calculated (re)-positioning vector to be applied with respect to Coordinate Systems the treatment delivery unit relates to.

The medPhoton IRS is a standalone imaging system designed to obtain TwoDimensional (2D) and Three-Dimensional (3D) X-ray images. The images visualize patient's anatomy whose information can be used to accurately position or re-position the patient undergoing radiotherapy treatment. The IRS consists of - · hardware called ImagingRing (IR) consisting of couch top, ring, detector, X-ray source, generator, etc .; - · software called ImagingRing Software Suite (ImRiSS), to orchestrate image acquisition and data processing: - . programmable logic controller (PLC) components and related software (e.g., ImagingRing Control System - IRCS), to execute and control image acquisition. The system is designed in a way such that it provides the following key features: - 1. During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest. - 2. The X-ray source and detector can move independently in order to enable nonisocentric acquisition trajectories (i.e., to focus on a selectable center of interest within the patient in an axial plane) and variable size of the axial Field Of View (FOV). - 3. The combination of imaging arm and couch top is designed to be directly attached to a range of Patient Positioning Systems (PPS) including multi-axis robotic devices. The imaging device is integrated with a couch top. The independently moveable components allow for acquisition of X-ray projective images. These provide the foundation for 2D planar imaging as well as acquisition and reconstruction of 3D ConeBeam Computed Tomography (CBCT) images around customizable centers of interest.