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510(k) Data Aggregation

    K Number
    K172869
    Device Name
    Discovery XR656 HD
    Manufacturer
    GE Hualun Medical Systems Co.Ltd.
    Date Cleared
    2017-10-20

    (30 days)

    Product Code
    KPR, IZF, 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
    The Discovery XR656 HD is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, 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. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. The device is not intended for mammographic applications.
    Device Description
    The Discovery XR656 HD Radiography X-ray System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and wireless digital detectors. 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 combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
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    K Number
    K171800
    Device Name
    OEC Elite MiniView
    Manufacturer
    GE Hualun Medical Systems Co.Ltd.
    Date Cleared
    2017-07-12

    (26 days)

    Product Code
    OXO, JAA
    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 Elite™ MiniView™ (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.
    Device Description
    The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment, and surgical procedures of the shoulders, limbs, and extremities. The system consists of a C-arm attached to an image processing workstation. A CsI(TI) -CMOS flat panel detector and the identical X-ray source monoblock are used for image acquisition. The C-arm supports the high-voltage generator, X-ray tube, X-ray controls, collimator, and the FPD. The C-arm is capable of performing linear (vertical, horizontal, orbital) and rotational motions that allow the user to position the X-Ray imaging components at various angles and distances with respect to the patient extremity anatomy to be imaged. The C and support arm are mechanically balanced allowing for ease of movement and capable of being "locked" in place using an electronically controlled braking system. The workstation is a stable mobile platform that supports the C-arm, image display monitor(s), image processing equipment/software, recording devices, data input/output devices and power control systems. The primary technology change for the subject device compared to the unmodified predicate OEC Elite MiniView, was to add an optional wireless footswitch which provides identical functionalities as the wired footswitch to control X-ray on and off.
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