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510(k) Data Aggregation

    K Number
    K251766
    Device Name
    TumorSight Viz
    Manufacturer
    SimBioSys, Inc.
    Date Cleared
    2025-07-08

    (29 days)

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

    SimBioSys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243189
    Device Name
    TumorSight Viz
    Manufacturer
    SimBioSys, Inc.
    Date Cleared
    2024-10-25

    (25 days)

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

    SimBioSys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). TumorSight Viz also includes user-configurable features for visualizing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.
    Device Description
    TumorSight Viz is an image processing system designed to assist in the visualization and analysis of breast DCE-MRI studies. TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application. Available features support: - . Visualization (standard image viewing tools, MIPs, and reformats) - . Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering) - . Communication and storage (DICOM import, retrieval, and study storage) The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer.
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    K Number
    K231130
    Device Name
    TumorSight Viz
    Manufacturer
    SimBioSys, Inc.
    Date Cleared
    2023-12-26

    (250 days)

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

    SimBioSys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). TumorSight Viz also includes user-configurable features for visualizing and analyzing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.
    Device Description
    TumorSight Viz is an image processing system designed to assist in the visualization and analysis of breast DCE-MRI studies. TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application. Available features support: - Visualization (standard image viewing tools, MIPs, and reformats) - Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering) - Communication and storage (DICOM import, retrieval, and study storage) The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer.
    Ask a Question

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