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510(k) Data Aggregation

    K Number
    K223144
    Device Name
    Galaxy System
    Manufacturer
    Noah Medical Corp.
    Date Cleared
    2023-03-01

    (148 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Noah Medical Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
    Device Description
    The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.
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