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510(k) Data Aggregation

    K Number
    K093495
    Device Name
    OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2010-11-19

    (374 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS

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

    The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

    Device Description

    The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert numbers/qualifications, adjudication methods), or study types (MRMC, standalone). The document is a 510(k) clearance letter from the FDA for an Ophthalmoscope Diagnostic Instrument Kit, primarily confirming substantial equivalence and outlining regulatory compliance requirements. It does not include a performance study summary.

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