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510(k) Data Aggregation

    K Number
    K110006
    Device Name
    OIS SYMPHONY IMAGE MANAGMENT SYSTEM
    Manufacturer
    OPHTHALMIC IMAGING SYSTEMS
    Date Cleared
    2011-05-18

    (135 days)

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

    OPHTHALMIC IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.
    Device Description
    The OIS Symphony System is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. OIS Symphony consists of image display via Symphony Web, Image Import via Symphony Import and integration of imaging performed in OIS WinStation. OIS Symphony is a software solution consistent with the predicate devices listed herein, using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Symphony provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
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    K Number
    K092374
    Device Name
    OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
    Manufacturer
    OPHTHALMIC IMAGING SYSTEMS
    Date Cleared
    2009-11-17

    (104 days)

    Product Code
    HKI, HJO, NFG
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.
    Device Description
    OIS EyeScan is a portable, modular imaging device, which is designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit). OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review and analysis. The device comprises a base unit, and interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.
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    K Number
    K982689
    Device Name
    WINSTATION RETINAL IMAGER
    Manufacturer
    OPHTHALMIC IMAGING SYSTEMS
    Date Cleared
    1998-10-23

    (81 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WinStation Retinal Imager™ has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segment (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
    Device Description
    Not Found
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