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510(k) Data Aggregation

    K Number
    K003236
    Device Name
    RETINADX
    Manufacturer
    REGULATORY ASSOCIATES, INC.
    Date Cleared
    2000-11-02

    (16 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RetinaDx Angiography System is intended for use by trained medical professionals (physicians, ophthalmic technicians, ophthalmic photographers or others with similar training) in a medical office, hospital or other medical setting. It is indicated when a medical professional suspects a patient could have damage or disease of the retina. It is used to take photographs of the patient's retina, which are then studied by the medical professional to get additional information about the retina to consider in his or her efforts to decide on a diagnosis and treatment plan.
    Device Description
    RetinaDx Digital Angiography System (Camera Ophthalmic)
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