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OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).

OTOPLAN is a Software as a medical Device (SaMD) which consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can - import DICOM-conform medical images, fuse supported images and view these images. - navigate through the images and segment ENT relevant structures (semi-automatic/automatic), which can be highlighted in the 2D images and 3D view. - use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency. - create a virtual trajectory, which can be displayed in the 2D images and 3D view. - identify electrode array contacts, lead, and housing of a cochlear implant to assess electrode insertion and position. - input audiogram-related data that were generated during audiological testing with a standard audiometer and visualize them in OTOPLAN. OTOPLAN allows the visualization of third-party information, that is, cochlear implant electrodes, implant housings and audio processors. The information provided by OTOPLAN is solely assistive and for the benefit of the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment.

CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. In planning, the desired needle configuration and performance is defined relative to the target anatomy. In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored. In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data. CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

The system consists of the following main components: - . A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera, and a computer. - . Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle. - CAS-One IR software: The software provides the step-by-step workflow assistance for needle ● navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.

OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological procedures (e.g., cochlear implantation).

OTOPLAN consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can import DICOM-conform medical images and view these images, navigate through the images and segment ENT-relevant structures (semi-automatic), which can be highlighted in the 2D images and 3D view, use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency, create a virtual trajectory, which can be displayed in the 2D images and 3D view, identify electrode array contacts of a cochlear implant to assess electrode insertion and position, and input audiogram-related data that were generated during audiological testing with a standard audiometer and visualize them in OTOPLAN. OTOPLAN allows the visualization of third-party information, that is, a cochlear implant electrode arrav portfolio. The information provided by OTOPLAN is solely assistive and for the benefit of the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment. OTOPLAN is designed to run on a PC and requires the 64-bit Microsoft Windows 10 operating system. A PDF Reader such as Adobe Acrobat is recommended to access the instructions for use. For computation and usability purposes, the software is designed to be executed on a computer with touch screen capabilities.

OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological procedures (e.g., cochlear implantation).

OTOPLAN consolidates a DICOM viewer, ruler function, and calculator function into one software platform. The user can - import DICOM-conform medical images and view these images. - navigate through the images and segment ENT-relevant structures (semi-automatic), which can be highlighted in the 2D images and 3D view. - use a virtual ruler to geometrically measure distances and a calculator to apply established formulae to estimate cochlear length and frequency. - create a virtual trajectory, which can be displayed in the 2D images and 3D view. - identify electrode array contacts of a cochlear implant to assess electrode insertion and position. - input audiogram-related data that were generated during audiological testing with a standard audiometer and visualize them in OTOPLAN. OTOPLAN allows the visualization of third-party information, that is, a cochlear implant electrode array portfolio. The information provided by OTOPLAN is solely assistive and for the user. All tasks performed with OTOPLAN require user interaction; OTOPLAN does not alter data sets but constitutes a software platform to perform tasks that are otherwise performed manually. Therefore, the user is required to have clinical experience and judgment. OTOPLAN is designed to run on a PC and requires the 64 bit Microsoft Windows 10 operating system. A PDF Reader such as Adobe Acrobat is recommended to access the instructions for use. For computation and usability purposes, the software is designed to be executed on a computer with touch screen capabilities. The minimum hardware requirements are: - 12.3in wide screen - 8GB of RAM - 2 core CPU (such as a 5th generation i5 or i7) - dedicated GPU with OpenGL 4.0 capabilities - 250GB hard drive

CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. In planning, the desired needle configuration and performance is defined relative to the target anatomy. In navigation, the instrument position is displayed telative to the patient and guidance for needle alignment is provided while respiratory levels are monitored. In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data. CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

The system consists of three main components: - A mobile navigation platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera and a computer. - Aiming device with trackable aiming insert: To aim the needles to their correct locations, the system uses an aiming device. The aiming device is attached to a multi-axis mechanical arm that can align the position of the aiming device around the expected needle entry position. The aiming device is first aligned to the desired entry point (translational alignment) and then alignment to the desired needle insertion angle is performed using a remote center of rotation principle (rotational alignment). There are two possible configurations of the aiming device. - Instrument adapter clamp with trackable marker shield: As an alternative to the aiming device, trackable markershields can be attached directly to rigid needles by means of an instrument adapter. Calibration of the needle geometry is performed with a calibration unit supplied by CAScination. - CAS-One IR software: The software provides the step-by-step workflow assistance for needle navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.

The CAS-One Liver system is indicated for open liver surgical procedures where image guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The CAS-One Liver system is indicated for open liver surgical procedures where image aujdance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. It visualizes the position and pose of surgical instruments relative to a three-dimensional model of the patients liver in real-time.