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The DirectRay™ Operator Console has application whenever the transmission of radiographic images and associated patient text data is desired to take place from an input device, such as any radiographic equipment which uses the DirectRay™ device, to any output device, such as hardcopy, softcopy, or archive devices.

The DirectRay™ Operator Console is that device, which when used with any X-ray generating equipment and the DirectRay™ device (Sterling Diagnostic Imaging Direct Radiography™ ' K#973206) allows the synchronization of the ready states of the DirectRay™ device and the X-ray generator, and allows the operator to acquire, preview and transmit image and associated text data along with exam administration report capabilities. In one version, this device will also integrate these functions with the typical functions of an X-ray console eliminating the need for a separate X-ray console. This device is located in the control booth and will usually be housed in a specially designed cabinet. An optional feature of the DROC is the ability to link the digital image with the hospital information/radiology information systems (HIS/RIS).

The iiSYS PACS System is a complete PACS System for the Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes. Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.

The iiSYS PACS System is a full featured PACS System capable of transmission, archive, display, and print of patient image and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information at remote facilities and at locations other than that at which it was acquired. Data may be received as digital information, video signals, or hard copy prints and may be reviewed via monitor or printed hardcopy. The iiSYS PACS system consists of the following major components: - Series of Viewing and Reading Workstations - Teleradiology devices for digitizing and transmission of images over wide area or local area networks for remote or at home review - Archive for short or long term storage - LINX Network system for secondary capture and transmission of images to other devices (workstation, telerad, printers, etc.) - Printers

These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.

Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet activated rare earth intensifying screens. The phosphor is niobium activated lutetium tantalate.

The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.

The Raven is a free standing device used to print diagnostic images on a polyester base for viewing on a standard view box and/or print reports and referral quality images on paper. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

The device accepts electrical image signals and produces hard copy images. The image signal source may be analog or digital formatted image data from image readers or unformatted image data from other imaging modalities (e.g. CT, MRI). The Sterling Raven Dry Imager uses the information in the image signals to control discrete elements in a print head which writes on the translating paper or Medical Imaging Film, a thermal recording media. The Raven has no laser, cathode ray tube, or optics. Like the predicate devices, the Raven does not use conventional light-sensitive silver halide photographic media, and thus requires no dark room, film processor, processing chemicals, water, drainage, or dryer ventilation. It produces no chemical waste, and requires no space for chemical storage. The major elements are the film magazine, transport mechanics, imaging electronics, and head.

The Raven is a free standing device used to print diagnostic images for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

The device accepts electrical image signals and produces hard copy images. The image signal source may be digital formatted image data from image readers or unformatted image data from other imaging modalities (e.g. CT, MRI). The image signal source may be analog or digital. The Helios Laser Imager uses the information in the image signals digitally record diagnostic images and patient data on a proprietary product specific medical imaging media. The Helios does not use conventional light-sensitive silver halide photographic media, requires no dark room, film processor, processing chemicals, water, drainage, or dryer ventilation. It produces no chemical waste, and requires no space for chemical storage.

This Premarket Notification 510(k) is being filed to cover additions to the LINX™ Networking System with LINX™ Laser Imager (K900935) to include all capabilities that we are adding to meet market demands. The basic product concept remains - to connect various image input devices to one or more output devices. That basic concept has been expanded to meet market demands: new image source interfaces new control interfaces new network interfaces more output devices supported new data types managed image transfer mechanisms (some output devices may require handling in the transmission path to the output device to compensate for differences in devices)

The LINX™ Networking System is a system to connect various image input devices to one or more output devices. Additions to the system include new image source interfaces, new control interfaces, new network interfaces, support for more output devices, management of new data types, and image transfer mechanisms.