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510(k) Data Aggregation

    K Number
    K022114
    Device Name
    IMPERIUM
    Manufacturer
    ELMSTECH, INC.
    Date Cleared
    2002-09-17

    (81 days)

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

    ELMSTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMPERIUM is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography (DSA), orthopedic, neurologic, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at physician's discretion.
    Device Description
    The IMPERIUM is a mobile c-arm x-ray imaging equipment consisting of a carm stand and a monitor trolley. The c-arm stand holds the high-frequency x-ray generator, x-ray tube assembly, x-ray controls, image intensifier and TV camera. Monitor trolley supports the image display monitors, image processing and recording devices. The IMPERIUM is designed to provide the user with smooth lincar and rotational movements around patient without need of further reorientations. The C-arm movements are fully motorized for ease of operation. The IMPERIUM is designed according to such principles as lower dosage, better image quality and manipulation, workflow enhancement, operator and patient comfort and versatility. The IMPERIUM can be operated at Fluoroscopy, Pulsed Fluoroscopy, Digital Radiography, Cassette Radiography, Digital Subtraction Angiography (DSA) and Roadman modes. Image processing and storage capabilities such as last image hold, recursive filtering, real time edge enhancement, real time zooming, image reversal, continuous image rotation, radiation-free collimation and contrast/brightness adjustment are possible under user control.
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