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510(k) Data Aggregation

    K Number
    K221329
    Device Name
    Eyer Retinal Camera NM-STD
    Manufacturer
    Phelcom Technologies
    Date Cleared
    2023-02-22

    (292 days)

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

    Phelcom Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the funan eye, surface of the human eye and surrounding areas
    Device Description
    The Eyer Retinal Camera NM-STD retinography is accompanied by accessories: dock station (1pc), lens protector (1 pc), allen wrench (1pc), eyecap (2 pcs) cleaning cloth (1 pc) and slit lamp adapter (1pc). Eyer Retinal Camera NM-STD is designed for use in a medical environment. Captured images and video are used for documentation. The images and videos are stored in an internal database of the smartphone application, in a security way. For the retinal function, Eyer Retinal Camera NM-STD is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Eyer Retinal Camera NM-STD has eleven fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the center by selecting the appropriate point. For the anterior function, Eyer Retinal Camera NM-STD has a white light source for imaging eye surface and surrounding areas, in this configuration the device does not make contact with the patient. The transfer of images to a PC is carried out via FTP, DICOM or CFIS communication, with the client responsible for the connection and subsequent storage. The Eyer Retinal Camera NM-STD, energy comes from the smartphone that has a rechargeable Li-lon battery and is charged when the device is docked on charge station, which is connected to the mains by power supply cable.
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