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Intended for use by a qualified/trained physician or technician for obtaining fluoroscopic and radiographic images of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients. Rx only.

The Insight Enhanced™ DRF is an upgrade package that is designed to be installed on existing fluoroscopic systems, referred to as host system, to convert the imaging chain from analog to digital. It is comprised of the Insight Enhanced™ DRF Digital Imaging chain and associated interfacing hardware. The Insight Enhanced™ DRF system includes medical grade monitors, computer, and flat panel detector. Interface boards, cabling, and signal converters are included for interfacing with the host system. The x-ray generator and x-ray tube are not modified in any way. A flat panel detector replaces the image intensifier and camera on the base system. All of the fundamental features and principles of operation Insight Enhanced™ DRF are identical to the predicate device, Insight Enhanced™ (K200369). Both systems are upgrade packages that replace an analog imaging chain with a new digital one. The main components of the product, the PC, software, and detector for the predicate device and for the subject device are identical. Mounting hardware and interfacing components differ to add compatibility to GE OEC 9800/9900 C-arms. Insight Enhanced™ DRF is designed as an upgrade package for General Electric Legacy and P500 fluoroscopy rooms. This submission adds compatibility to a device, the OEC 9800/9900.

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