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510(k) Data Aggregation

    K Number
    K251730

    Validate with FDA (Live)

    Device Name
    LIA Console (542-7)
    Manufacturer
    Leadoptik, Inc.
    Date Cleared
    2025-12-19

    (196 days)

    Product Code
    NQQ
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K182616
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT).

    The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

    Device Description

    The LIA Console is indicated for use as an imaging tool in the evaluation of human tissue microstructure in the tracheobronchial tree by providing two-dimensional, cross-sectional, real-time depth visualization using Optical Coherence Tomography (OCT).

    The LIA Console is intended to be used only in conjunction with the LIA-1 Catheter in order to function as intended.

    LIA Console consists of the following main parts:

    1. Monitor: 24-inch multi-touch display monitor allowing software user interface.

    2. Catheter Driving Unit (CDU): Electromechanical and optical interface between the LIA Console and the LIA-1 Catheter. A rotary motor inside drives the LIA-1 Catheter to form 360-degree side view real-time imaging.

    3. Catheter Driving Arm (CDA): A supporting arm allowing CDU positioning, mobility and flexibility during the procedure.

    4. Image Engine: The main body of the LIA Console contains laser source, computing unit, data acquisition and power distribution module and other components.

    5. Caster: Four caster wheels installed at the base provide mobility for the LIA Console. Each caster is equipped with a brake that can lock the LIA Console in place as needed.

    6. OCTICA Software: A proprietary GUI-based software that controls data acquisition, rotary motor and other hardware components to enable real-time OCT imaging of tissue microstructure.

    AI/ML Overview

    N/A

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