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510(k) Data Aggregation

    K Number
    K182626
    Device Name
    OEC One
    Manufacturer
    GE Hualun Medical Systems Co., Ltd.
    Date Cleared
    2018-11-16

    (53 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™ mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
    Device Description
    The OEC One™ 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, vascular, neurologic, 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 an image intensifier on the top of the C-arm and the X-ray Source assembly at the opposite end. The OEC One™ is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow 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.
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    K Number
    K172700
    Device Name
    OEC One
    Manufacturer
    GE HUALUN MEDICAL SYSTEMS CO., LTD.
    Date Cleared
    2017-11-09

    (63 days)

    Product Code
    OWB, JAA, OXO
    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™ mobile C-arm system is designed to provide fluoroscopic and digital spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, critical care, and emergency procedures.
    Device Description
    The OEC One™ 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, 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
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