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510(k) Data Aggregation

    K Number
    K190056
    Device Name
    KOWA VK-2s
    Manufacturer
    KOWA Co. Ltd. CHOFU
    Date Cleared
    2019-02-12

    (32 days)

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

    KOWA Co. Ltd. CHOFU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic ophthalmic cameras.
    Device Description
    The VK-2s consists of five types of software models including the: - VK-2s Standard . - . VK-2s VX-20 - VK-2s nonmyd ● - VK-2s nonmydWX - VK-2s Viewer . The VK-2s Standard, VK-2s VX-20, VK-2s nonmyd, and VK-2s nonmydWX are all software executed on a capture PC. The software acquires images from a retinal camera that the control software captures and puts on the capture PC. The software acquires images of the eye, stores images and processes images. The software displays acquired and processed images which are stored in a Server's database. The only difference between these four software programs are the devices that are supported for providing images: VK-2s Standard This software only supports images from: - KOWA VX series cameras, ● - KOWA nonmyd series cameras . - and supports file import. VK-2s VX-20 This software only supports images from: - . KOWA VX-20 series cameras, - and supports file import. ● VK-2s nonmyd This software only supports images from the KOWA nonmyd series cameras. VK-2s nonmydWX This software only supports images from the KOWA nonmydWX cameras. VK-2s Viewer This is a software executed on a viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in a server database. This software does not support image capture. The VK-2s software also takes advantage of three software packages included with the VK-2s. These are: VK-Montage Software This software allows the operator to create montages using multiple images VK-Scan VK Scan is software which can be used to import images located in a specified folder. VK-DDV The detailed database viewer provides advanced searching, viewing, image processing, printing, and reporting for your VK-2s database.
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