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510(k) Data Aggregation

    K Number
    K110040
    Device Name
    OMNIVISION
    Manufacturer
    MODERN MODULE INC
    Date Cleared
    2011-01-26

    (20 days)

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

    MODERN MODULE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images.OmniVision receives images from imaging modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images. It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists. OmniVision is not intended for the acquisition of mammographic image data.
    Device Description
    OmniVision is a Picture Archiving and Communications System (PACS), as is the predicate Device dicomPACS. All of them have been developed to acquire, store, communicate, display and process medical images. They offer features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions. OmniVision has a modular system architecture, It consists of the basic application viewer for image viewing and processing, image storage and communication, and a number of other modules for database management, image acquisition, printing etc. OmniVision conforms to the DICOM (Digital Image and Communications in Medicine) standard.
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