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510(k) Data Aggregation

    K Number
    K230627
    Device Name
    Zilia Ocular FC (ZIL-10002)
    Manufacturer
    Zilia Inc.
    Date Cleared
    2023-11-20

    (259 days)

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

    Zilia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions. Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.
    Device Description
    The Zilia Ocular Fundus Camera (Zilia Ocular FC) is a non-contact, stand-alone device designed to image the eye fundus. The device includes a base, a head support, an onboard computer with a 15.6'' touch-screen display and an optical head. A joystick, situated at the base of the device, controls the movements of the optical head to enable adequate positioning. The touch-screen display also includes a user interface allowing the user to control the device and acquire and display patient data and images. The Zilia Ocular FC uses near-infrared (NIR) light-emitting diodes (LEDs) as illumination during alignment to the patient's pupil, and a white LED during focusing and imaging of the eye fundus. The region of the eye fundus being imaged can be modified by changing or moving the fixation target. The images are saved and stored on the onboard computer. The dimensions of the Zilia Ocular FC are 620 mm (L) by 360 mm (W) by 500 mm (H) and it weighs about 32 kg.
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