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510(k) Data Aggregation

    K Number
    K251894
    Device Name
    Himaging Bronchscope System
    Manufacturer
    Himaging Technology (Shanghai) Co., Ltd.
    Date Cleared
    2025-09-23

    (95 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K233671,K173727
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K233671

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

    The sterile single-use flexible video bronchoscopes are designed to be used with the Himaging endoscopic video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

    The Himaging bronchoscope system is applicable to hospital environment or medical office environment.

    The Himaging bronchoscopes are sterile single-use devices designed for use in adults.

    Device Description

    The subject device, Himaging Bronchoscope System, is consisting of a single-use flexible video Bronchoscope and an endoscopic video processor. The subject device has been designed to be used for endoscopy within the airways and tracheobronchial tree.

    AI/ML Overview

    N/A

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