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510(k) Data Aggregation

    K Number
    K093520
    Device Name
    VIVOSIGHT TOPICAL OCT SYSTEM
    Manufacturer
    MICHELSON DIAGNOSTICS LTD.
    Date Cleared
    2010-01-05

    (53 days)

    Product Code
    NQQ,NOQ
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIVOSIGHT TOPICAL OCT SYSTEM

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

    VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.

    Device Description

    Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary and an FDA clearance letter for the "VivoSight Topical OCT System".

    It primarily discusses:

    • Device Identification: Trade Name, Common Name, Classification, Predicate Device.
    • Intended Use: "Intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization."
    • FDA Clearance: Confirmation of substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested table and study details based on the input.

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