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510(k) Data Aggregation

    K Number
    K130374
    Device Name
    OMNI-VUE 2 SYSTEM
    Manufacturer
    GENESIS DIGITAL IMAGING, INC.
    Date Cleared
    2013-08-29

    (196 days)

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

    GENESIS DIGITAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Omni-Vue 2™ System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc .; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by FDA
    Device Description
    Omni-Vue 2™ System makes possible the capturing, storage, distribution, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the System can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
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    K Number
    K073062
    Device Name
    OMNI-VUE SYSTEM
    Manufacturer
    GENESIS DIGITAL IMAGING, INC.
    Date Cleared
    2008-03-10

    (132 days)

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

    GENESIS DIGITAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Omni-Vue™ System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. The Omni-Vue device allows limited image processing capability: "sharpening preset" and window leveling function. For image editing; the only an "L" or "R" marker can be added to the image but it must be already defined in the original image DICOM header as received by the system. "L" or "R" can not be added to the image if left & right is not defined in the original image. The device provides scout line which is a reference line and is drawn on the AP image to display the location of the slice being viewed. In multi series images, whenever one image is clicked, scout line will be drawn on other series which is crossed direction.
    Device Description
    Omni-Vue™ System makes possible the capturing, storage, distribution, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the System can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
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