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510(k) Data Aggregation

    K Number
    K070528
    Device Name
    PHILIPS ESSENTA DR
    Date Cleared
    2007-03-09

    (14 days)

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

    PHILIPS MEDICAL SYSTEMS GMBH, DMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley). The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
    Device Description
    The Essenta DR is a multifunctional system, in which a swivel arm holds the x-ray tube and the x-raydetector. The generator, x-ray tube housing assembly, beam limiting device, deector, including the workstation for image processing and the optional mobile x-ay table (trolley) are known components. The geometry of the Essenta DR contains a central column, on which the height-adjustable and rotatable swivel arm is mounted. The rotatable detector and the rotatable x-ray tube with control section are mounted at the swivel arm. This enables the radiation beam to be adjusted to any position on a vertical plane. A second control section on the detector carrier allows positioning on the patient to be carried out at the detector itself. The vertical adjustment of the swivel arm, the rotation of the swivel arm and the SID adjustment are motorized. It esables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the auto-positioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.
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