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510(k) Data Aggregation

    K Number
    K142897
    Device Name
    P200DTx
    Manufacturer
    OPTOS PLC.
    Date Cleared
    2015-01-16

    (105 days)

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

    OPTOS PLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The P200DTx scanning laser ophthalmoscope is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.It is also indicated for use as a widefield scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using Indocyanine Green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.
    Device Description
    The Optos P200DTx is a scanning laser ophthalmoscope that uses lasers as a light source to illuminate the eye. The device consists of the following components and accessories: - . A scanhead which houses the lasers, the scanning elements of the light input path and the light return path including the detectors which convert light into electronic signal. The scanhead with its integral head and chin rest forms the key patient interface in conjunction with a facepad and associated aperture where the eye is placed. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system. - . A touchscreen is attached by a cable to the scanhead to assist the operator in optimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken. Patient positioning and image capture can also be conducted via a hand control. - o A personal computer with a monitor to allow image review and storage in a Windows environment.
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