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The VFSS Pro Mobile system is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities, and at the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. The VFSS Pro™ Mobile system is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients except neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications.

The VFSS Pro Mobile system is a mobile imaging system that can acquire, process, and display fluoroscopic images. It can be easily positioned within a room and moved from room within a facility. To provide the ability to perform fluoroscopic examinations as needed within a facility. The system employs a low-powered mono-block generator and a dynamic flat-panel detector so that it can be powered through a single-phase 120VAC power outlet. The imaging chain is powered by the Insight Agile DRF Digital Imaging System which allows the operator to view and enhance high-definition fluoroscopy images up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Agile DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a dynamic flat panel detector, monitors, and an image processor PC. This device employs either the Vieworks FXDD-1212G or the Rayence 1212FCA digital x-ray receptor panels (previously cleared, see Reference devices). The device software employed is from the Reference device Insight Agile DRF.