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510(k) Data Aggregation

    K Number
    K240828
    Device Name
    OEC One ASD
    Manufacturer
    GE Hualun Medical Systems Co. Ltd.
    Date Cleared
    2024-12-27

    (276 days)

    Product Code
    OXO, JAA, OWB
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Hualun Medical Systems Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.
    Device Description
    The OEC One ASD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end. The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The subject device is labelled as OEC One ASD.
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    K Number
    K231892
    Device Name
    Definium Pace Select
    Manufacturer
    GE Hualun Medical Systems Co. Ltd.
    Date Cleared
    2023-09-12

    (76 days)

    Product Code
    KPR, MOB, MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Hualun Medical Systems Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. This device is not intended for mammographic applications.
    Device Description
    The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs.
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