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510(k) Data Aggregation

    K Number
    K200385
    Device Name
    CONTINUUM PACS
    Manufacturer
    Integrated Ophthalmic Systems, Inc.
    Date Cleared
    2020-03-16

    (27 days)

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

    Integrated Ophthalmic Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CONTINUUM PACS is a software system to store, manage and display patient data, diagnostic data, videos and images from computerized ophthalmic diagnostic imaging devices.
    Device Description
    CONTINUUM PACS is an ophthalmic image management system that has been designed to store, retrieve and provide browser-based review of reports, videos and images which were generated by ophthalmic imaging devices. CONTINUUM PACS has a central database for patient information and historical exams. CONTINNUM PACS is installed on the user's server and communicate with the networked imaging devices. The users review images, reports, and videos via their existing browser software.
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