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510(k) Data Aggregation

    K Number
    K102529
    Device Name
    D2RF DIGITAL DYNAMIC REMOTE SYSTEM
    Manufacturer
    STEPHANIX RADIOLOGICAL SYSTEMS
    Date Cleared
    2010-10-07

    (35 days)

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

    STEPHANIX RADIOLOGICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D'RF Digital Dynamic Remote System Is indicated for use in generating fluoroscopic Images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
    Device Description
    D'RS is a direct digital dynamic remote-controlled fluoroscopy and radiography system equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray Images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital Images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table.
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