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510(k) Data Aggregation

    K Number
    K243664
    Device Name
    Sentinel Camera
    Manufacturer
    AI Optics
    Date Cleared
    2024-12-17

    (20 days)

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

    AI Optics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.
    Device Description
    The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable. The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored. The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina 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. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images. The transfer of images to the AI Optics Server is carried out via Wi-Fi communication. The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.
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