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510(k) Data Aggregation

    K Number
    K223048
    Device Name
    Medisystem Pacs
    Date Cleared
    2023-06-23

    (267 days)

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

    Medilab Manutencao E Sitemas Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MediSystem PACS is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediSystem PACS displays and manages diagnostic quality DICOM images. MediSystem PACS is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediSystem PACS is not intended for diagnostic use on mobile devices. Contraindications: MediSystem PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
    Device Description
    The MediSystem PACS is a Web-based DICOM medical image viewer that allows downloading. reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediSystem PACS is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediSystem PACS enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software. Supported Web browsers are: Microsoft Edge 79 or later, Mozilla Firefox 58 or later, Google Chrome 63 or later.
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