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The Insight Agile DRF 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 and 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. (Rx Only)

The Insight Agile DRF Digital Imaging System is a modification of Insight Enhanced DRF, a previously cleared (K200396) fluoroscopic imaging chain employing a flatpanel digital detector (Vieworks 1212G) to replace the image intensifier and video camera on GE R&F systems (P500, Legacy and Advantx). This system has now been modified in the following manner: 1) the digital interface board (DIB) that provides communications with the GE systems has been replaced with a software program that utilizes virtual serial ports. 2) Another software program has been added to allow the system to communicate with and control a Source-Ray x-ray generator. The generator interface provides for Automatic Brightness Stabilization (ABS) control and optional manual control through a graphical user interface on the Insight Aqile image acquisition screen. 3) A second dynamic flat-panel detector (Rayence 1212FCA, K202722) has been integrated to provide an alternate digital detector. 4) the software risk assessment has been changed from minor to moderate. 5) the Indications for Use has been changed to that of the predicate device. With these modifications, Insight Agile DRF is a fluoroscopic imaging chain that can acquire, process, and display fluoroscopic images when installed on any suitable positioning system in a fixed room, on a mobile or portable stand. Another purpose of this application is to expand the indications for use.

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

The Insight Enhanced™ DRF Digital Imaging System is designed to provide an additional imaging acquisition device to the existing image intensifier, camera and user interface with a dynamic flat-panel detector (dFPD) on the following FDA approved R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The subject fluoro system Insight Enhanced is based on the predicate Insight Essentials. The following dynamic digital detectors are added to the predicate system: Vivix-D 1212G and Vivix-D 1717G. The x-ray generator, beam-limiting device and patient positioner, necessary for a full fluoroscopy system are not part of the subject device software stays unchanged from the predicate Insight Essentials DRF. The Insight Enhanced™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Enhanced™ 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 fluoroscopic video camera, monitors, and an image processor PC.

Intended for use by a qualified/trained doctor on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

The Insight Essentials™ DRF Digital Imaging System is designed to replace the video camera and user interface on the following FDA cleared R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The x-ray generator, beam-limiting device and patient positioner. necessary for a full fluoroscopy system are not part of the subject device. The Insight Essentials™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Essentials™ 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 fluoroscopic video camera, monitors, and an image processor PC.