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510(k) Data Aggregation

    K Number
    K100439
    Device Name
    MEDIWORKS SLIT LAMP
    Manufacturer
    SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
    Date Cleared
    2010-07-16

    (149 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MediWorks Model S280, S280S, S350, S350S Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

    Device Description

    AC-powered slit lamp biomicroscopes

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes an FDA 510(k) clearance for medical devices (slit lamps), outlining the regulatory approval process and general requirements. However, it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

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