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510(k) Data Aggregation

    K Number
    K203058
    Device Name
    CloudVue
    Date Cleared
    2020-10-29

    (21 days)

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

    International Medical Solutions Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CloudVue is a software application that displays medical image data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup. CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images. CloudVue displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage only when a full workstation is not available. Usage for mammography is for reference and referral only.
    Device Description
    CloudVue is a software application that allows for the display of medical image data within a web browser without installing client software. Conceptually, the application comprises two components: the web viewer and the web server. The server is installed on any computer that meets the minimum system requirements and is configured to communicate with a DICOM archive. The server is capable of DICOM and DICOMweb communication, which allows the connected DICOM archive to exist on a physical server or in the cloud, giving institutions the flexibility to choose a system infrastructure that is best suited to their needs. CloudVue provides fast and secure access to full-fidelity CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, and XA images using Chrome, Safari, Firefox, or Edge web browsers. With interactive features, such as: multi-study viewing, multi-monitor support, customized screen and tool layouts, annotation saving and loading, measurement drawing and calibration, reference lines, key images, multi-planar reformatting (MPR), MIP, VR rendering, and image link sharing, CloudVue is a feature-rich solution that informs diagnostic decision-making by healthcare professionals. CloudVue also supports these same features across the following devices: Windows 10 and higher, macOS X and higher, iPad Pro 200 generation and higher, and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere. The display is not part of the subject device, CloudVue, however, is an essential component of a fullyfunctional imaging system. The end user will view the medical images on the display monitor of their choice.
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