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510(k) Data Aggregation

    K Number
    K132921
    Device Name
    GALAXY PLUS
    Date Cleared
    2014-01-17

    (122 days)

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

    MEDIEN INTERNATIONAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
    Device Description
    The digital diagnostic x-ray system consists of a generator, a tube, an x-ray console, a beam limiting device, an image receptor, a u-arm stand and software. The digital panels supplied are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. Product features: This system is designed to maintain the alignment between a tube and the image receptor, regardless of the angle on the image receptor or image tilt positions. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on patients. Its flexibility makes the system ideal for all patient examinations including the standing, sitting and lying patient positions.
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    K Number
    K093816
    Device Name
    DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600
    Date Cleared
    2010-10-05

    (298 days)

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

    MEDIEN INTERNATIONAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Galaxy 900 is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Galaxy 900 is not intended for mammography. The Galaxy 1600 Digital CCD X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. The Galaxy 1600 is not intended for mammography.
    Device Description
    The Digital Radiography System, Galaxy is an optical based digital x-ray imager. This device should be integrated with an operating PC. The visible light is deflected by a mirror to a high-resolution CCD camera that produces a digital image. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic. The BLADE software acquires X-ray image and viewing the image. Get image from detector, process it to ease the diagnostic, save it in database and manage it.
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