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510(k) Data Aggregation

    K Number
    K111531
    Device Name
    RHA2020
    Manufacturer
    ANNIDIS HEALTH SYSTEMS CORP.
    Date Cleared
    2011-07-08

    (36 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANNIDIS HEALTH SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.
    Device Description
    The Annidis RHA2020U multi-spectral digital ophthalmoscope which presents eye care practitioners (optometrists and ophthalmologists) with a series of retinal spectral images from each eye of a patient. The images each have a spatial resolution of over four million pixels spread over a visual range of greater than 40 degrees. The instrument also captures an image of the iris and pupil. The device is arranged in four major hardware subcomponents and one remote software component used for clinical visualization and tracking purposes. The four hardware components are listed below: - The Optical Head Unit (OHU) contains the camera and the illuminating LEDs and is aligned to the eye of the sitting patient whose head is stabilized using a chin-rest and forehead brace. The OHU contains the optical and electrical systems required to capture images of the eye and the means to align the patient with the device. - The Host Computer (HC), a Linux-based host computer that serves as the operator interface. - The Universal Power Supply (UPS), a custom designed power supply receives A power from the AC mains and supplies power using low voltage DC to the host computer, the display, and the optical head unit (OHU). - The Touch Screen Display, that displays information from the host computer, configures the optical head unit for patient comfort, visualizes the patient data and triggers image capture.
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