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510(k) Data Aggregation

    K Number
    K202084
    Device Name
    DeepLook PRECISE
    Manufacturer
    Date Cleared
    2021-04-09

    (256 days)

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

    DeepLook Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software and must not be used in isolation when making patient management decisions. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Megapixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists. DeepLook PRECISE, is not intended for use on mobile devices.
    Device Description
    DeepLook PRECISE, is a software application that works embedded in PACS/EIS or OEM viewers. It provides automated measurement, replacing manual digital calipers currently used to measure objects in digital medical imaging. It is a Windows OS service that uses XML messaging to receive Commands from the viewer application: it processes results independently and returns requested data to the viewer application via the same XML messaging. The software is not compiled within the viewer's application. As a result, integration is simplified and limited to establishing XML protocols for reciprocal Commands. DeepLook PRECISE can operate on an individual workstation, local servers or in Cloudbased applications. The software uses patented shape-recognition processes to analyze Regions of Interest (ROIs) identified by a trained medical user (i.e., imaging technologist, radiologist, phvsician or researcher). When requesting a measurement, the user triggers a set of XML Commands via the viewer interface. The primary Command is a request for a measurement of an object located within an ROI designated by the user using a mouse to click on the location of a suspected object. DeepLook receives the Command, processes the area within the ROI and assembles the candidate shapes (and all relevant metrics) and returns a full set of displays (bundled and prioritized) that depict the possible boundaries of the object. To facilitate initial viewing, DeepLook PRECISE designates a default shape; this shape is recommended as the best depiction of the targeted margin of the object. The selection of the default shape from the display stack is determined by a set of deterministic algorithms that sort for the best candidate shape based on shape recognition ratios developed by DeepLook. Based on training and professional skill, a user can use simple keystroke Commands or a track ball or mouse wheel to move through the entire stack of alternative margins (shapes) and select the one that they conclude best represents the targeted object. Once a candidate shape has been chosen, the user has the option to extend or contract any specific section of the margin in order to include or exclude a feature they deem relevant. Any alteration of the contours of the displayed margin will recalculate the overall measurement metrics (i.e., calculate two new axis measurements, and the area and estimated volume). The results will instantly appear with the modified margin. The Commands to accept the default shape-display or select alternative shape-displays and any modification of selected shape-displays are all executed using keystroke or track ball functions that are initiated by the user through the viewer interface. Each resulting shape includes all relevant measurement metrics when displayed, allowing for quick comparison and selection. For illustrative purposes, the software offers a colorization display of the internal shapes within a candidate margin: each of the shapes within the outer margin of a targeted object or anatomical structure is assigned a calibrated color. This is offered solely to assist the user in distinguishing the shape components when making a final selection. The colorization is not a decision-support or diagnostic tool. The measurements and graphical display can be saved. Depending on the viewer configuration, this data can be saved 1) to the hard drive of the workstation; 2) to a server on the premises or in the Cloud; 3) in a structured report; or 4) configured to comply with DICOM data fields and saved to the PACS. The location of the saved display will be determined by the viewer manufacturer and/or the user. The displays of DeepLook PRECISE described above offer the user consistent measurement of each shape. The modification functions provide the user with maximum flexibility to adjust the default shape or any other shapes in the display stack. The user can also decline all suggested shapes generated by DeepLook PRECISE and use standard mouse-operated digital calipers to measure the target object. The final configuration of the user interface (i.e., keystrokes, track ball and hot-key Commands) will be determined by each vendor that integrates DeepLook PRECISE. To assist the vendor during integration, each XML Command and display option is illustrated separately in this manual. This provides the integrator with the option of selecting some or all the functions and to determine the best Commands to incorporate, consistent with its own user interface. DeepLook PRECISE is stand-alone Windows OS service designed to permit maintenance and performance improvements without the need to modify established XML protocols used to send and receive Commands. This eliminates the need for additional vendor integrations when patches and/or updates are required to DeepLook PRECISE's Windows OS service.
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