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510(k) Data Aggregation

    K Number
    K234096

    Validate with FDA (Live)

    Device Name
    MonoStereo
    Manufacturer
    MedicalTek Co., Ltd.
    Date Cleared
    2024-09-19

    (268 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MonoStereo is intended to be used together with 2D monoscopic endoscope systems to provide simulated 3D visualization for observation during ENT diagnostic and therapeutic procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA clearance letter for a device called "MonoStereo", outlining regulatory information and general controls. It does not include details on performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.

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