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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.

This is a new generation of Ceiling Suspension Radiographic System. This system is characterized by its simple and functional design. Thanks to its vertical and horizontal displacements, the suspension can cover almost all the room positions in which it is installed allowing all radiographic procedures. The system is modular and supports different configurations, such as radiographic system without radiographic table or without Wall Stand. The X-ray image receptors used in this system are digital detectors. X-ray film and Computed Radiography (CR) image receptors can be used but they rarely are these days. The device software used is the CANON CXDI which is supplied unmodified by CANON (Clearance numbers above). It has a moderate level of concern. The Radiographic System ChallengeX AP is provided with Auto-positioning, Auto-centering and Auto-tracking functions and it is composed of: Ceiling Suspension (OTC), Radiographic Table, Wall Stand, High Voltage X-ray Generator and acquisition image software. Auto-tracking allows the X-ray Tube to follow the Receptor when it changes position or the other way around while the SID remains constant. The "Auto" features were present and validated in the predicate system.

Intended for use by a qualified/trained doctor or technician on both adult and pediatic subjects for taking diagnostic radiographic exposures of the skull, spinal column, 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

These are redesigned versions of our predicate mobile digital diagnostic xray systems. They feature motorized movement and full battery operation. Various Canon digital Xray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit PhoeniX has a Basic configuration or Advanced configuration. Advanced configurations include: - Second screen on head assembly. - Smooth movements of head assembly. - Telescopic arm in four steps instead three steps for basic configuration. The Mobile X-Ray unit is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on Mobile X-ray unit and it is displayed on touch screen. It is the user interface and compatible digital detectors are listed above. All have FDA Clearance. The Advanced configuration has a second Touch Screen Monitor located on head-assembly. The PhoeniX Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode, that is, operating without mains being present or unplugged from mains. The unit is connected to mains to charge the batteries; New rating: the input voltage range goes from 100 V~ to 240 V~, 1 phase, 1.1 kVA. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit PhoeniX. This new X-Ray generator for PhoeniX Mobile X-Ray Unit has a radiogenic unit mounted on headassembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit PhoeniX is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES: - New: XRR-3331 insert. - New: E7886 insert. New: Manual Beam Limiting Device from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.