Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K232045
    Device Name
    MeVis Liver Suite
    Manufacturer
    MeVis Medical Solutions AG
    Date Cleared
    2023-10-27

    (109 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MeVis Medical Solutions AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver and liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homogenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used for manual segmentation, user-defined manual labeling, and 3D visualization of: - abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, and pancreas) - liver related vascular structures (i.e., bile ducts, hepatic vein, portal vein, and inferior vena cava) - lesions inside and adjacent to the liver The tools for manual segmentation and 3D visualization are applicable for CT and MR imaging studies. In addition to the manual segmentation tools, MeVis Liver Suite provides AI based semi-automatic pre-segmentation tools for liver, hepatic artery, hepatic vein restricted to CT scans of potential living liver donors with healthy livers and intended for: - Liver: contrast enhanced late-venous and venous phase - Hepatic vein: contrast enhanced late-venous and venous phase - Portal vein: contrast enhanced late-venous and venous phase - Hepatic artery: contrast enhanced arterial phase Using MeVis Liver Suite, users can evaluate the segmented objects by exploring, and manually correcting: - the volume of the segmented abdominal organs (see above) - the volume of the segmented lesions inside and adjacent to the liver - the volume of the manually defined parts of the liver - by defining separation planes ("separation proposals") - from vascular territories that are derived from the user-defined labeling of the liver related vascular structures - 3D visualizations of user-defined (vascular) tumor margins (coloring of area based on user-defined margin sizes/ distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - based on user provided values, calculation of liver volume to body weight ratios (i.e., estimated weight for remnant or graft, body surface area, graft to recipient body weight ratio, graft to SLV ratio, remnant to body weight ratio). Using a manual spatial registration of the images, the segmented objects (created on different CT phases and MRI sequences) can be visualized together. The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, and treatment decisions. MeVis Liver Suite is not intended for the anatomical systems integumentary, skeletal, muscular, lymphatic, respiratory, nervous, reproductive, and cardiovascular (excluding hepatic). MeVis Liver Suite does not support the following application areas: real time viewing, diagnostic review, mage manipulation, optimization, virtual colonoscopy, and automatic lesion detection. MeVis Liver Suite does not utilize high-resolution displays or display drivers and should not be used as a replacement for a PACS workstation.
    Device Description
    MeVis Liver Suite is an image analysis software and intended to be used for visualization of hepatic imaging studies derived from CT and MR scanning devices (image source: single- and multiframe DICOM). MeVis Liver Suite supports physicians in their workflow for evaluating the liver, related vascular anatomy, and the volume of liver vascular territories for treatment planning, preoperative evaluation of surgery strategies, and post-procedure or therapy follow-up assessment of the hepatic system and related vascular structures. The information created with MeVis Liver Suite is intended to be used only in addition to the original images, clinical data, and the real anatomical and clinical situation. Physicians make all final patient management, assessment, and treatment decisions. Software and Operating System MeVis Liver Suite is a standalone software application that can be installed on any PC that runs on Windows 10 which meet the hardware requirements. Supported Modalities DICOM compatible CT and MR image data with or without contrast. The tools for manual segmentation and 3D visualization (see below) are applicable for CT and MR image data with the exception of the Al based semi-automatic pre-segmentation tools. The semi-automatic pre-segmentation tools are restricted to CT scans of potential living liver donors with healthy livers. Image import and selection MeVis Liver Suite supports image analysis for multiphase contrast enhanced CT, dynamic contrast enhanced MRI, and MRCP. MeVis Liver Suite only allows import of homoqenous image series (i.e., image and pixel size must be constant within each series) and with orthogonal image matrix (without a gantry tilt). Images with a resolution of > 5mm slice spacing are not suitable for image analysis with MeVis Liver Suite. MeVis Liver Suite can be used to manually select DICOM images (CT and MR) for import. The user can visually inspect the images, if the anatomical structures are visible and if the image resolution and image quality is acceptable for the manual segmentation and the user's needs. Seqmentation and 3D visualization MeVis Liver Suite provides multiple contouring tools for manual segmentation. The user has full control over the workflow and decides which structures to segment. 3D visualizations are created on demand. The following segmentation workflows are available: . Abdominal organs MeVis Liver Suite is intended to be used to manually segment and visualize liver, stomach, duodenum, spleen, kidney, gallbladder, or pancreas using contouring tools. Users can inspect and manually correct, add, and delete their segmentation until they are satisfied with the result. The following tools are available: - o Freehand contouring - o Region Growing . Liver related vascular structures MeVis Liver Suite is intended to be used to manually segment and visualize bile ducts. hepatic artery, hepatic vein, portal vein, and inferior vena cava, including the option to manually classify different vessels of the vascular branches by assigning them userdefined labels. Users can inspect and manually correct, add, and delete their segmentation until they are satisfied with the result. The following tools are available: - o Freehand drawing and freehand contouring - Region Growing o - o Edit and label 3D tree . Lesions inside and adjacent to the liver MeVis Liver Suite is intended to be used to manually seqment, visualize, and label user identified lesions inside and adjacent to the liver using: - o Freehand contouring MeVis Liver Suite does not identify or highlight lesions or other abnormalities. Additionally, the user can use Al based semi-automatic pre-segmentation of liver and liver related vascular structures to create a segmentation proposal. The semi-automatic preseqmentation uses locked/non adaptive Al networks. ● Semi-automatic pre-segmentation of the liver - Supported modalities - CT, contrast enhanced late-venous and venous phase - o Limitations ■ Only intended for living donor liver transplantation cases (healthy livers) - Semi-automatic pre-segmentation for liver related vascular structures ● - Supported modalities o - Hepatic vein: CT, contrast enhanced late-venous and venous phase . - Portal vein: CT, contrast enhanced late-venous and venous phase - . Hepatic artery: CT, contrast enhanced arterial phase - o Limitations - Only intended for living donor liver transplantation cases (healthy livers) Evaluation of segmented objects Users can evaluate the segmented objects by exploring, and manually correcting: - Volume MeVis Liver Suite calculates the volume (via voxel-counting of segmentation mask) and displays the volume information to the user for the following manually segmented objects: - o Abdominal organs (i.e., liver, stomach, duodenum, spleen, kidney, gallbladder, pancreas) - o Lesions inside and adjacent to the liver - Manually defined parts of the liver o - . "Separation proposals" The user can manually define separation planes that part the liver into virtual parts. The user manually labels the parts as either "resection"," graft" (for coloring the 3D visualization of the user-defined part with a red color), or "remnant" (green color) - = "Vascular territories" Using the user-defined labeling (name and color) of vessel subtrees, the software calculates seqmentation masks for the corresponding vascular territories within the liver - 3D visualizations of user-defined (vascular) tumor margins (coloring of area based . on user-defined margin sizes/distances - between the edges of user-defined lesions in relation to the edges of user-defined vascular structures of the liver) - o The distance of vascular structures to user selected lesions can be visualized with colored 3D visualizations: - · with color coded vascular structures ("vascular tumor margins") - . with color coded voxels around a lesion inside the liver ("tumor margins") - Based on user provided values, calculation of liver volume to body weight ratios ● MeVis Liver Suite provides the following calculations: - Estimated Weight for Remnant and Graft O - Body Surface Area o - Graft to Recipient Body Weight Ratio o - Graft to Standard Liver Volume (SLV) Ratio o - Remnant Volume to Body Weight Ratio o Manual spatial registration MeVis Liver Suite supports performing a manual spatial registration of the images from different modalities and studies (CT and MR). The user can manually align the imported images visually in pairs on top of each other using manual rigid registration. Reporting Using MeVis Liver Suite, the user can report results of the image analysis in different formats (DICOM for archiving, with DICOM definitions for 2D segmentation and 3D volumes; HTML report).
    Ask a Question
    K Number
    K201501
    Device Name
    Veolity
    Manufacturer
    MeVis Medical Solutions AG
    Date Cleared
    2021-02-23

    (263 days)

    Product Code
    OEB, LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MeVis Medical Solutions AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veolity is intended to: - display a composite view of 2D cross-sections, and 3D volumes of chest CT images, - allow comparison between new and previous acquisitions as well as abnormal thoracic regions of interest, such as pulmonary nodules, - provide Computer-Aided Detection ("CAD") findings, which assist radiologists in the detection of solid pulmonary nodules between 4-30 mm in size in CT images with or without intravenous contrast. CAD is intended to be used as an adjunct, alerting the radiologist - after his or her initial reading of the scan - to regions of interest that may have been initially overlooked. The system can be used with any combination of these features. Enabling is handled via licensing or configuration options.
    Device Description
    Veolity is a medical imaging software platform that allows processing, review, and analysis of multi-dimensional digital images. The system integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-theshelf personal computer (PC). It can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. Veolity is intended to support the radiologist in the review and analysis of chest CT data. Automated image registration facilitates the synchronous display and navigation of current and previous CT images for follow-up comparison The software enables the user to determine quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. Veolity automatically performs the measurements for segmented nodules, allowing lung nodules and measurements to be displayed. Afterwards nodule segmentation contour lines can be edited by the user manually with automatic recalculation of geometric measurements post-editing. Further, the application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings in order to determine growth patterns and compose comparative reviews. Veolity requires the user to identify a nodule and to determine the type of nodule in order to use the appropriate characterization tools. Additionally, the software provides an optional/licensable CAD package that analyzes the CT images to identify findings with features suggestive of solid pulmonary nodules between 4-30 mm in size. The CAD is not intended as a detection aid for either part-solid or non-solid lung nodules. The CAD is intended to be used as an adjunct, alerting the radiologist – after his or her initial reading of the scan – to regions of interest that may have been initially overlooked.
    Ask a Question
    K Number
    K120207
    Device Name
    VISIA
    Manufacturer
    MEVIS MEDICAL SOLUTIONS AG
    Date Cleared
    2012-04-23

    (90 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEVIS MEDICAL SOLUTIONS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visia™ is a medical image processing software application intended for the visualization of images from various sources (e.g., Computed Tomography (CT), Magnetic Resonance (MR), etc). The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia™ is not meant for primary diagnostic interpretation of mammography.
    Device Description
    Visia™ is a medical imaging software platform that allows processing, review, and analysis of multidimensional digital images acquired from a variety of medical imaging modalities. Visia™ offers flexible workflow options to aid clinicians in the evaluation of patient anatomy and pathology. The Visia™ system integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server client configuration across a computer network. Images can be displayed based on physician preferences using configurable viewing options or hanging protocols. Visia™ provides the clinician with a broad set of viewing and analysis tools to annotate, measure, and output selected image views or reports.
    Ask a Question
    K Number
    K120484
    Device Name
    VISIA ONCOLOGY
    Manufacturer
    MEVIS MEDICAL SOLUTIONS AG
    Date Cleared
    2012-03-27

    (39 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEVIS MEDICAL SOLUTIONS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visia Oncology is a medical software application intended for the visualization of images from a variety of image devices. The system provides viewing, quantification, manipulation, and printing of medical images. Visia Oncology is a noninvasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.
    Device Description
    Visia™ Oncology is a noninvasive medical image processing software application intended for the visualization of images from various sources such as Computed Tomography systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Oncology integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. Visia™ Oncology is designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.
    Ask a Question
    K Number
    K113701
    Device Name
    VISIA NEURO
    Manufacturer
    MEVIS MEDICAL SOLUTIONS AG
    Date Cleared
    2012-02-16

    (62 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEVIS MEDICAL SOLUTIONS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visia™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic review, and vessel visualization. Data can be visualized in both 2D and 3D views. BOLD fMRi Review: The BOLD MRI feature is useful in identifying small susceptibility changes arising from neuronal activity during performance of a specific task. Diffusion Review: The diffusion review feature is intended for visualization and analysis of the diffusion of water molecules through brain tissue. Fiber Tracking Review: The fiber tracking feature uses the directional portion of the diffusion vector to track and visualize white matter structures within the brain. Dynamic Review: Dynamic review feature is intended for visualization and analysis of MRI dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary. Vessel Visualization: The vessel feature is used to identify and visualize the vascular structures of the brain. 3D Visualization: The 3D visualization feature allows image data to be reconstructed as 3D objects that are visualized and manipulated on a 2D screen.
    Device Description
    Visia™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Neuro integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. The software provides functionality for processing and analyzing both anatomical and physiologic/functional imaging datasets. Specifically, the software includes user defined processing modules for image registration, blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), diffusion imaging, fiber tracking, dynamic imaging, and vessel imaging. Processed images are stored as separate files from the original data such that the original data is preserved. Images may be displayed based on physician preferences using configurable layouts, or hangings. Visia™ Neuro provides the clinician with a broad set of viewing and analysis tools in both 2D and 3D. The software includes tools to annotate, measure, and output selected image views or user defined reports.
    Ask a Question
    K Number
    K113337
    Device Name
    VISIA DYNAMIC REVIEW
    Manufacturer
    MEVIS MEDICAL SOLUTIONS AG
    Date Cleared
    2011-12-30

    (46 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEVIS MEDICAL SOLUTIONS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visia™ Dynamic Review is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. Visia™ Dynamic Review supports evaluation of dynamic MR data. Visia™ Dynamic Review automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics (parametric image maps). Furthermore, it performs other user-defined post-processing functions such as image subtractions; multi-planar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. Visia™ Dynamic Review can also be used to provide measurements for diameters, areas and volumes. Furthermore, Visia™ Dynamic Review can evaluate the uptake characteristics of segmented tissues. Visia™ Dynamic Review also displays images from a number of other imaging modalities; however, these images must not be used for primary diagnostic interpretation. When interpreted by a skilled physician, Visia™ Dynamic Review provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of Visia™ Dynamic Review analysis.
    Device Description
    Visia™ Dynamic Review is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. Visia™ Dynamic Review supports evaluation of dynamic MR data. Visia™ Dynamic Review integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard offthe-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. Visia™ Dynamic Review automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics (parametric image maps). Furthermore, it performs other user-defined post-processing functions such as image subtractions; multi-planar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source images can also be displayed based on physician preferences using configurable viewing options or hanging protocols. Visia™ Dynamic Review provides the clinician with a broad set of viewing and analysis tools to annotate, measure, and output selected image views or user defined reports. Furthermore, Visia™ Dynamic Review can evaluate the uptake characteristics of segmented tissues. Visia™ Dynamic Review also displays images from a number of other imaging modalities; however, these images must not be used for primary diagnostic interpretation.
    Ask a Question

    Page 1 of 1