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510(k) Data Aggregation

    K Number
    K162909
    Device Name
    CSX-30 Flat Panel Detector
    Manufacturer
    Canon, Inc. – Medical Equipment Group
    Date Cleared
    2017-01-27

    (102 days)

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

    Canon, Inc. – Medical Equipment Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The flat panel detector CSX-30 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical-care and emergency room procedures or other imaging applications at the physician's discretion. The device is intended to replace spot-film device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
    Device Description
    The CSX-30 is a digital radiography flat panel detector that can take fluoroscopic and spot radiographic images of any part of the body. It directly converts the X-ray images captured by the sensor into high-resolution digital images. The instrument is a component of an x-ray system and as such cannot be used outside of such a system. This unit converts the X-rays into digital signals. Not intended for mammography applications.
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