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510(k) Data Aggregation

    K Number
    K050866
    Device Name
    CENTRION 500 C-ARM SYSTEM
    Manufacturer
    Date Cleared
    2005-04-27

    (22 days)

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

    OSTEOSYS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Centrion 500 C-Arm System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures. Clinical applications include, but are not limited to, general surgery, gastro-intestinal, urologic, orthopedic, neurologic, vascular, and emergency room procedures. The system may also be used for other imaging applications at the physician's discretion.
    Device Description
    The Centrion 500 C-Arm System. Is a digital C-Arm-type fluoroscopic system. It includes nearly every feature that exists on currently marketed System: "It interacts noany, while enclosing those features in a products, nact system, and adding a Real-Time Pulsed Fluoroscopy more offical by John Pulsed Fluoroscopy mode can significantly reduce the dose to the patient, without compromising image quality. Dose reductions of up to 85% are possible.
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