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510(k) Data Aggregation

    K Number
    K230772
    Device Name
    Quantib Prostate
    Manufacturer
    Quantib BV
    Date Cleared
    2023-04-17

    (27 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
    Device Description
    Quantib Prostate (QPR) is an extension to the Quantib AI Node (QBX) software platform that enables analysis of prostate MRI scans. QPR makes use of QBX functionality, and includes 3 specific QPR modules. The three specific modules of QPR are as follows: - An automatic processing module that performs input checks, prostate (sub-region) segmentation, multi-parametric MRI (mpMRI) image registration, computation of a biparametric combination image, and optionally crops the images around the prostate. - A two-step user-interaction module in which the user can: - edit the computed prostate segmentation (QBX functionality) and determine PSA density (QPR-specific functionality). - view multi-parametric MRI images (QBX functionality), and segment (QBX functionality) and analyze potential lesions (QPR-specific functionality). This extension also shows the prostatic sub-region segmentation and biparametric combination image overlay. (QPR-specific functionality). - An automatic processing module that collects all results, and creates the report and DICOM output so that they can be exported back to the user.
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    K Number
    K221106
    Device Name
    Quantib Prostate
    Manufacturer
    Quantib BV
    Date Cleared
    2022-05-13

    (28 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
    Device Description
    Quantib Prostate is an extension to the Quantib Al Node software platform and enables analysis of prostate MRI scans. Quantib Prostate makes use of Quantib Al Node functionality, and includes the following specific Quantib Prostate modules: - An automatic processing module that performs prostate and prostate sub-reqion segmentation and multi-parametric MRI image registration and computation of a biparametric combination image. - A user-interaction module in which the user can edit and approve the computed prostate segmentation and determine PSA density. - A user-interaction module in which the user can view multi-parametric MRI images. segment and analyze potential lesions and set and view PI-RADS properties. This module also shows the prostatic sub-region segmentation and biparametric combination image overlav. - An automatic processing module that collects all results, and creates the report and DICOM output so that they can be exported back to the user.
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    K Number
    K202501
    Device Name
    Quantib Prostate
    Manufacturer
    Quantib BV
    Date Cleared
    2020-10-11

    (41 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
    Device Description
    Quantib Prostate is an extension to the Quantib Al Node software platform and enables analysis of prostate MRI scans. Quantib Prostate makes use of Quantib Al Node functionality, and includes the following specific Quantib Prostate modules: - An automatic processing module that performs prostate segmentation and multiparametric MRI image registration. - A user-interaction module in which the user can edit and approve the computed prostate segmentation and determine PSA density. - . A user-interaction module in which the user can view multi-parametric MRI images, and segment and analyze potential lesions. This extension will also apply a mathematical operation on the input images to combine information from the MRI sequences into a single combination image. - . An automatic processing module that collects all results for exporting and transferring back to the user.
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    K Number
    K200899
    Device Name
    Quantib AI Node
    Manufacturer
    Quantib BV
    Date Cleared
    2020-06-15

    (73 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib AI Node is a software platform that provides visualization tools and enables external postprocessing extensions for medical images. The software platform is designed to support in qualitative and quantitative measurement, analysis, and reporting of clinical data. The software platform provides means for storing of data and transferring data from and into other systems such as PACS. The software platform provides an interface to integrate processing extensions and custom input/output modules. Quantib AI Node functionality includes: - · Interface for multi-modality and multi-vendor input/output of data, such as DICOM data - · Initiation of extensions to process the data based on properties of the data - · Interface for extensions that provide custom data import/output, post-processing, and user interface functionality - · User interface for visualization and annotation of medical images, and for correction and confirmation of results generated by post-processing extensions Quantib AI Node is intended to be used by trained medical professionals.
    Device Description
    Quantib Al Node (QBX) is a stand-alone software platform that enables external post-processing extensions for medical images and provides visualization and annotation tools. It can automatically process data received via a DICOM connection and automatically export results to external DICOM nodes. It allows for configuring workflows that can contain user-interaction steps to review and correct automatic results.
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    K Number
    K182564
    Device Name
    Quantib ND
    Manufacturer
    Quantib BV
    Date Cleared
    2018-12-27

    (100 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib™ ND is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyperintensities. Volumetric measurements may be compared to reference centile data. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Quantib™ ND is a software application on top of Myrian®.
    Device Description
    Quantib™ ND is a post-processing analysis module for Myrian®, which provides 3D image visualization tools that create and display user-defined views and streamlines interpretation and reporting. It is intended for automatic labeling, visualization, and volumetric quantification of identifiable brain structures from magnetic resonance images (a 3D T1-weighted MR image, with an additional T2-weighted FLAIR MR image for white matter hyperintensities (WMH) segmentation). The segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments. Quantib™ ND provides quantitative information on both the absolute and relative volume of the segmented regions. The automatic WMH segmentation is to be reviewed and if necessary. edited by the user before validation of the segmentation, after which volumetric information is accessible. Quantib ND consists of Quantib ND Baseline, which provides analysis of images of one time-point, and Quantib ND Follow-Up, which provides longitudinal analysis of images of two time-points. Quantib ND Follow-Up can only process images that have been processed by Quantib ND Baseline. Quantib ND is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the radiology specialist in quantitative reporting.
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    K Number
    K173939
    Device Name
    Quantib Brain
    Manufacturer
    Quantib BV
    Date Cleared
    2018-03-09

    (73 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib™ Brain is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ Brain output consists of segmentations, visualizations and volumetric measurements of grey matter (GM), white matter (WM), and cerebrospinal fluid (CSF). The output also visualizes and quantifies white matter hyperintensity (WMH) candidates. Users need to review and if necessary, edit WMH candidates using the provided tools, before validation of the WMHs. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Quantib™ Brain is a post-processing plugin for the GE Advantage Workstation (AW 4.7) or AW Server (AWS 3.2) platforms.
    Device Description
    Quantib™ Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 13.0 Ext 4 (or higher). It is intended for automatic labeling, visualization, and volumetric quantification of identifiable brain structures from magnetic resonance images (a 3D T1-weighted MR image, with an additional T2-weighted FLAIR MR image for white matter hyperintensities (WMH) segmentation). The segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments. Quantib™ Brain provides quantitative information on both the absolute and relative volume of the segmented regions. The automatic WMH segmentation is to be reviewed and if necessary, edited by the user before validation of the segmentation, after which volumetric information is accessible. Longitudinal analysis can be performed for the brain tissue segmentation and WMH seqmentation in order to compare multiple exams of an individual patient. Quantib Brain is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the radiology specialist in quantitative reporting.
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    K Number
    K163013
    Device Name
    Quantib Brain 1.2
    Manufacturer
    Quantib BV
    Date Cleared
    2017-01-06

    (70 days)

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

    Quantib BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib™ Brain is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ Brain output consists of segmentations, visualizations and volumetric measurements of grev matter (GM), white matter (WM), and cerebrospinal fluid (CSF). The output also visualizes white matter hyperintensity (WMH) candidates. Users need to review and if necessary, edit WMH candidates using the provided tools, before validation of the WMHs. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Quantib™ Brain is a post-processing plugin for the GE Advantage Workstation (AW 4.7) or AW Server (AWS 3.2) platforms.
    Device Description
    Quantib™ Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher). It is intended for automatic labeling, visualization, and volumetric quantification of identifiable brain structures from magnetic resonance images (a 3D T1-weighted MR image, with an additional T2-weighted FLAIR MR image for white matter hyperintensities (WMH) segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments. Quantib™ Brain provides quantitative information on both the absolute and relative volume of the segmented regions. The automatic WMH segmentation is to be reviewed and if necessary, edited by the user before validation of the segmentation, after which volumetric information is accessible. Longitudinal analysis can be performed for the brain tissue segmentation and WMH segmentation in order to compare multiple exams of an individual patient. Quantib Brain is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the radiology specialist in quantitative reporting.
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    K Number
    K153351
    Device Name
    Quantib Brain 1
    Manufacturer
    QUANTIB BV
    Date Cleared
    2016-06-17

    (210 days)

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

    QUANTIB BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantib™ Brain is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ Brain output consists of segmentations, visualizations and volumetric measurements of grey matter (GM), white matter (WM), and cerebrospinal fluid (CSF). The output also visualizes and quantifies white matter hyperintensity (WMH) candidates. Users need to review and if necessary, edit WMH candidates using the provided tools, before validation of the WMHs. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Quantib™ Brain is a post-processing plugin for the GE Advantage Workstation (AW 4.7) or AW Server (AWS 3.2) platforms.
    Device Description
    Quantib™ Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 6. It is intended for automatic labeling, visualization, and volumetric quantification of identifiable brain structures from magnetic resonance images (a 3D T1-weighted MR image, with an additional T2-weighted FLAIR MR image for white matter hyperintensities (WMH) segmentation). The segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments. Quantib™ Brain provides quantitative information on both the absolute and relative volume of the segmented regions. The automatic WMH segmentation is to be reviewed and if necessary, edited by the user before validation of the segmentation, after which volumetric information is accessible. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the radiology specialist in quantitative reporting.
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