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510(k) Data Aggregation

    K Number
    K202928
    Device Name
    DV. Target
    Manufacturer
    Date Cleared
    2021-04-02

    (185 days)

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

    Deepvoxel INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DV.Target is a software application that enables the routing of DICOM-compliant data (CT Images) to automatic image processing workflows, using machine learning-based algorithms to automatically delineate organs-at-risk (OARs). Contours generated by DV.Target may be used as an input to clinical workflows for treatment planning in radiation therapy. DV.Target is intended to be used by trained medical professionals including radiologists, radiation oncologists, dosimetrists, and physicists. DV.Target does not provide a user interface for data visualization. Image data uploaded, auto-contouring results, and other functionalities are managed via an administration interface. Thus, it is required that DV.Target be used in conjunction with appropriate software, such as a treatment planning system (TPS), to review, edit, and approve for all contours generated by DV.Target. DV.Target is only intended for normal organ contouring, not for tumor or clinical target volume contouring.
    Device Description
    The proposed device, DV.Target, is a standalone software that is designed to be used by trained medical professionals to automatically delineate organs-at-risk (OARs) on CT images. This OARs delineation function, often referred as auto-contouring, is intended to facilitate radiation therapy workflows. Supported image modalities include CT and RTSTURCT. DV.Target can automatically delineate major OARs in three anatomical sites --- Head & Neck, Thorax, and Abdomen & Pelvis. It receives CT images in DICOM format as input and automatically generates the contours of OARs, which are stored in DICOM format and in RTSTRUCT modality. The deployment environment of the proposed device is recommended to be a local network with an existing hospital-grade IT system in place. DV.Target should be installed on a specialized server supporting deep learning processing. After installation, users can login to the DV.Target administration interface via browsers from their local computers. All activities, including autocontouring, are operated by users through the administration interface. In addition to auto-contouring, DV.Target also has the following auxiliary functions: - User interface for receiving, updating and transmitting medical images in DICOM format; - User management; - Processed image management and output (RTSTRUCT) file management. Once data is routed to DV.Target auto-contouring workflows, no user interaction is required, nor provided. The image data, auto-contouring results, and other functionalities can be managed by DV.Target users via an administration user interface. Third-party image visualization and editing software, such as a treatment planning system (TPS), must be used to facilitate the review and editing of contours generated by DV.Target.
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