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The Adora DRFi is a direct radiography and radioscopy, universal and permanently installed diagnostic X-ray system with a flat panel detector, which allows the acquisition of a wide range of Xray examinations. It is intended for use in generating diagnostic and radioscopic images of human anatomy. The Adora DRFi X-rav system is intended for use by trained and qualified personnel at the entire body of both adult and pediatric patients, and exposures may be acquired with the patient in supine, standing or sitting positions as well as with the patient in e.g., a wheelchair or on a stretcher. Radiographic procedures can take place with the detector in free position as well as fixed in the docking station: whereas radioscopic procedures may only take place when the detector is fixed in the docking station. The Adora DRFi is not for mammography examinations.

The Adora DRFi x-ray system is a ceiling suspended universal x-ray system using direct radiography and radioscopy on flat panels for diagnostic purposes. The system can be used for acquisition of a wide range of radiographic and radioscopic x-ray examinations of the whole body, on both adult and pediatric patients. The patients may be lying on the Adora table, in a hospital bed or on a stretcher, using the flat panel's ability to be placed either inside or outside its housing for radiographic examinations. Radioscopic examinations, however, can only be made with the flat panel in the housing suspended in one of the two telescopes. The patients may also be standing on the floor, sitting on a chair or in a wheelchair. Examinations which can be performed on Adora X-ray systems; Radiography for Pelvis Supine, Pelvis Standing, Knee, and Radioscopy for Esophagus, Tube placement, knee. The positioning of the ceiling suspended X-ray tube and the flat panel relative to the patient and each other are controlled by the operator, either through a joystick or via pre-programmed auto-positions activated by the operator. The Adora X-ray system is a main powered, permanently installed system for use in hospitals and x-ray clinics and is intended solely for use by healthcare professionals, trained in and qualified for the use of medical xray equipment for diagnostic purposes.

The Intelli-C is indicated for use as a multipurpose diagnostic X-ray system for universal radioscopic and fluoroscopic studies. With its C-arm and digital flat detector, it can perform a range of applications including interventional procedures, vascular procedures, specialized applications including angiographic studies of the entire body on adults and paediatrics. The Intelli-C system is only indicated for use by trained professionals. The Intelli-C is not intended for mammography studies.

The Intelli-C device that we wish to bring to market is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies. This type of device is typically used in departments with a single fluoroscopy installation that benefit from the versatility of multi-purpose systems that allow a wider range of examinations than a standard fluoroscopy unit. In larger departments such systems can provide backup for other fluoroscopy installations, for example in case of breakdown. As with most multi-purpose systems, the Intelli-C has the patient tabletop and C-arm assembly supported on a main column from which the complete unit can be elevated and tilted. The tabletop is supported only at the foot end providing good, all round access to the patient. The C-arm supports the X-ray tube and image detector assembly and patient coverage is achieved through a combination of C-arm movements and table top movements. The C-arm has angulation and rotational movements, and the source to detector distance is variable. The image detector can be positioned above or below the tabletop depending on the specific examination requirement. The control room control panel for gantry movements, imaging system, generator and collimator are located in the control room. To facilitate interventional studies to be performed on this type of system, most controls are duplicated on a mobile tableside control panel. The imaging system is normally connected to PACS and Hospital Information System, e.g. patient lists, through the hospital network. The Intelli-C device will be offered in two main variants: NRT REF No.: 03400000 Device name: Intelli-C, Right side suspended table NRT REF No.: 03400010 Device name: Intelli-C, Left side suspended table The main systems will be offered with a range of options and accessories as listed in section 11 of this application.