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510(k) Data Aggregation

    K Number
    K200275
    Device Name
    OVision Imaging System
    Date Cleared
    2020-03-03

    (28 days)

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

    Ophthalmic Labs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OVision Imaging System is a software program that is intended for use in the collection, storage, and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments. The software system is indicated for use with retinal camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
    Device Description
    The OVision Imaging System is a software system that collects, stores, and maintains images of the retina and anterior segment of the eye. The Ovision Imaging System is used together with retinal cameras or digital camera imaging devices. In operation, the retinal camera will be operated as normally intended, with the OVision Imaging System capturing images of the patient. The OVision Imaging System does not alter or control the parameters of the retinal camera. The OVision Imaging System software accessory captures images from USB or Firewire digital cameras that are commercially available for both color and monochromatic imaging. The digital camera output of the fundus camera is tethered to the commercially available computer via a USB or FireWire cable. The OVision Imaging System software system receives the images captured by the retinal camera or digital camera. The images are stored in the computer's random access memory (RAM) and then saved on the local storage of the computer. The patient and exam information are stored in the system's database. The OVision Imaging System attaches directly to an existing retinal camera or digital camera via a communication cable. The user is able to operate the fundus camera in the manner it was intended, either viewing and focusing on the patient's retina through the eye piece or through the external monitor. During operation, the digital camera will transfer captured images to the computer to then store on its local drive.
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