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510(k) Data Aggregation

    K Number
    K180306
    Device Name
    Nexy
    Manufacturer
    Next Sight srl
    Date Cleared
    2018-06-08

    (126 days)

    Product Code
    HKI
    Regulation Number
    886.1120
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    Applicant Name (Manufacturer) :

    Next Sight srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
    Device Description
    The Nexy medical device is an automatic eye-fundus camera without the use of a mydriatic agent, designed to take color photos of the retinal fundus with a 45° field. The device consists of two fundamental components: the eye-fundus camera and the tablet which represents the user interface where running a dedicated software application. The instrument body includes: optical head, forehead and cheekbones rests and a base. The device is provided also with a front lens cap, a power cord and AC/DC adaptor. Through the tablet, the user starts the automatic examination that provides as output the photo of the patient's retina saved in the internal database of the device in JPEG format. The device can be used in a hospital environment, public and private health clinics and in public and private environments where eye or systemic diseases are screened. The device must be used by medical personnel in some cases assisted by health professionals and/or optometry professionals. Users must be adequately trained in the use of the device and informed about the risks and side effects as well as being in possession of the qualifications required by law.
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