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510(k) Data Aggregation

    K Number
    K242120
    Device Name
    OTOPLAN
    Manufacturer
    Cascination AG
    Date Cleared
    2025-04-11

    (266 days)

    Product Code
    QQE
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    QQE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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).
    Device Description
    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.
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    K Number
    K220300
    Device Name
    OTOPLAN
    Manufacturer
    Cascination AG
    Date Cleared
    2022-06-24

    (142 days)

    Product Code
    QQE, THE
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    QQE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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).
    Device Description
    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.
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    K Number
    K203486
    Device Name
    Otoplan
    Manufacturer
    CAScination AG
    Date Cleared
    2021-08-20

    (266 days)

    Product Code
    QQE, JAK, LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Product Code :

    QQE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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).
    Device Description
    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
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