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510(k) Data Aggregation

    K Number
    K070678
    Device Name
    DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST
    Manufacturer
    SWISSRAY INTERNATIONAL, INC.
    Date Cleared
    2007-05-02

    (51 days)

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

    SWISSRAY INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
    Device Description
    The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.
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    K Number
    K050718
    Device Name
    DDRCOMBI TRAUMA
    Manufacturer
    SWISSRAY INTERNATIONAL, INC.
    Date Cleared
    2005-05-26

    (66 days)

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

    SWISSRAY INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class II (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms. The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position.
    Device Description
    The major system components are: fix height adjustable patient table, X-ray generator, X-ray tube, Collimator, stand, ceiling suspension, digital AddOn bucky (4 CCD cameras), Image processing software and monitors.
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    K Number
    K973710
    Device Name
    DIGITAL ADD ON MULTI SYSTEM
    Manufacturer
    SWISSRAY INTERNATIONAL, INC.
    Date Cleared
    1997-12-18

    (80 days)

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

    SWISSRAY INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swissray Tellerav AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipuroose or dedicatedapplications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position.
    Device Description
    The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.
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