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510(k) Data Aggregation

    K Number
    K131314
    Device Name
    DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
    Manufacturer
    SWISSRAY MEDICAL AG
    Date Cleared
    2013-06-25

    (49 days)

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

    SWISSRAY MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ddrCruze™ is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. {Not for mammography}
    Device Description
    This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.
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    K Number
    K123005
    Device Name
    DDRVERSA MOTION
    Manufacturer
    SWISSRAY MEDICAL AG
    Date Cleared
    2012-12-07

    (71 days)

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

    SWISSRAY MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ddR Versa™ Motion System is intended for use by a qualified/trained doctor or technician on subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
    Device Description
    ddRVersa™ Motion uses the same core technology as our ddRElement but is modified in that: The supplier for the digital x-ray receptor panel has changed. The system can now accommodate two digital x-ray receptor panels instead of just one. A Wi-Fi digital x-ray receptor panel may be chosen as the second panel. The tubestand is changed from a C-arm configuration to an overhead plus wall stand configuration. The table is changed from non-motorized to motorized. The generator supplier has been changed. The collimator has been changed.
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    K Number
    K110828
    Device Name
    DDRELEMENT
    Manufacturer
    SWISSRAY MEDICAL AG
    Date Cleared
    2011-08-23

    (152 days)

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

    SWISSRAY MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ddRElement is a Digital Radiography system developed to be used for Medical General Radiography examinations on standing, seated and supine patients.
    Device Description
    The ddRElement is a Digital Radiography system.
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    K Number
    K052943
    Device Name
    DDRFORMULA AND DDRFORMULA PLUS
    Manufacturer
    SWISSRAY MEDICAL AG
    Date Cleared
    2005-12-15

    (56 days)

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

    SWISSRAY MEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked 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) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked 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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