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510(k) Data Aggregation

    K Number
    K000368
    Device Name
    EYECAP IMAGING SYSTEM
    Manufacturer
    CLEMENT CLARKE INTL., LTD.
    Date Cleared
    2000-05-04

    (90 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EYECAP IMAGING SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.

    Device Description

    EyeCap Imaging System

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the EyeCap Imaging System, which primarily states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested table or answer the specific questions about the study, sample sizes, ground truth, or expert qualifications.

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