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510(k) Data Aggregation

    K Number
    K973756
    Device Name
    EYE SYS VISTA
    Date Cleared
    1997-11-13

    (42 days)

    Product Code
    Regulation Number
    886.1350
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EYE SYS VISTA

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

    The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner.

    The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices . Corners topogital pho for potient screening become the standard of care documentation, corneal operative corneal surgery portu defermination and follow- up, as well as assisting in the and follow-up lenses. of contact

    Device Description

    Not Found

    AI/ML Overview

    This appears to be an FDA 510(k) clearance letter from 1997 for the "Eye Sys Vista TM" device. This document primarily focuses on regulatory clearance and substantial equivalence.

    Therefore, the provided text does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These types of details are typically found in the 510(k) summary or the full 510(k) submission, not in the clearance letter itself.

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