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Agfa's DX-Si system is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to column radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. The DS-Xi is not indicated for use in mammography. Use with separately cleared accessories allows the DX-Si to be conveniently used in generating urological, tomographic, pediatio and dental images.

The predicate and new devices are nearly identical computed radiography imaging systems. The DX-Si (new device) is a combination of previously cleared systems combined and marketed as a single system. The devices are the DX-S Digitizer with NX workstation and Siemens OEM version of its Multix Top x-ray system. The new device includes an interface that allows users to select initial xray exposure settings and review exposure parameters from the digitizer workstation. The basic principles of operation are unchanged.

AGFA's WEB1000 software is intended for installation on standard hardware meeting minimum specifications. The system is intended for viewing, assembling, organizing, sharing, and displaying patient images and demographic information. Images stored on the WEB1000 can be part of your evolving workflow. The WEB1000 can also be used remotely over a hospital intranet or over the Internet. When used by trained and qualified professionals the WEB1000 may be used for reviewing and referral image data collected from various modalities including mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.

WEB1000™ is a software package, which may be marketed as a software only solution, as well was in conjunction with standard PC hardware. WEB1000™ is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to WEB1000™ are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols. Images sent to WEB1000™ can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The WEB1000™ applet can be used for the purposes of viewing images over a hospital intranet, or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device. WEB1000™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to WEB1000™ . WEB1000™ is intended for reference viewing of medical data. It is not for the purposes of diagnosis. Images viewed from WEB1000™ are used from reference purposes only. Diagnostic reports created from diagnostic viewing application and distributed through WEB1000™ can be used for treatment of a patient.

The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to the PACS system. These images can be aimed at images helping the surgeon plan the actual prosthetic implant. These plans can also be shown to surgical placement of the implant. They will undergo and to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. The application consists of guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and and operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons surgiour ownershow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy. The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

The CR50.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR50.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.

The CR50.0, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the CR50.0 system utilizes an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally, printed or sent to a Picture Archiving and Communications System (PACS) in DICOM format. The CR50.0 is very similar to the CR25.0. It has a new scanning system that improves scan time and an image plate with an improved phosphor. However, the basic principles of operation are unchanged.

The Radiotherapy Solution Based on CR25.0 is indicated for producing simulation and quality control images for use in radiation therapy planning and quality control.

The Radiotherapy Solution Based on CR allows the application of Portal Imaging in a very wide dose range (1 MU - 400 MU's and higher) by using two different Portal Imaging Cassette types, which are optimised for image quality at their intended dose range. The Radiotherapy Solution Based on CR supports both low- and high-dose applications (sometimes called localisation and verification portal imaging). Not only does the system enable the acquisition of the images under the typical Radiotherapy conditions, the specific requirements for these images are also met which allows their use by the typical "next-in-line" radiotherapy applications. Typical "next-in-line" applications for simulation imaging are, for instance, image comparison and bloc compensator/MLC calculations. For portal imaging, a typical "next-in-line" application is image comparison with a reference image (this can be a simulation image or DRR: comparisons are made between hardcopy prints or on a digital workstation).

The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.

The ADC Compact Plus, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact Plus system utilizes an "imaging plate." a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in a PACS network in DICOM format. The CR25.0 is very similar to the ADC Compact Plus and the ADC Solo. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. Instead of upgrading the currently marketed economy system called the ADC Solo, components of the high-end ADC Compact Plus were reintegrated into a compact lower-cost system, resulting is no loss of resolution or other measures of image quality.

The Embrace™ Diagnostic PACS Workstation is intended for softcopy reading and diagnosis by Radiologists. It is also intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US). The Embrace™ DS3000 Diagnostic PACS Workstation is intended for use with rno Embraoo ved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality images (1800) images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US). The Embrace™ DS3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with EDA approved monitors and only when viewing Lossless format images. The Embrace™ DS3000 Diagnostic PACS Workstation is also intended for softcopy reading and diagnosis by Radiologists.

IMPAX Client Embrace™ delivers a diagnostic softcopy breast imaging workstation for the Women's Care initiative at AGFA. The following features are available: · Display of regionally approved DICOM DR Digital Mammography Images (MG SOP class) · Display of regionally approved DICOM CR Digital Mammography Images (CR SOP class) · Embrace™ product branding The Hardware configuration of Embrace™ will consist of the following: | System (Per Host Machine): | Dell Precision™ Workstation 650;<br>Compaq xw6000 | |----------------------------|-----------------------------------------------------------------| | Number & Details of CPU's | 1 or 2 CPU's depending on configuration | | Hard Drive space: | 40GB IDE | | CD-ROM: | Yes | | Floppy: | Yes | | Network interfaces: | System comes with an integrated<br>10/100/1000 Ethernet adapter | | Power Supplies: | Default | | Chassis: | Tower | | Peripherals: | Microsoft IntelliMouse or IntelliMouse<br>Explorer; Keyboard | Embrace™ will support the following monitors: - BARCO Mammography MeDis 5MP CRT monitor package -- MGD . 521M - BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU) .

The Agfa IMPAX OT3000 Orthopedic Workstation is designed as an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. Along with basic diagnostic display station functionality the software is intended to read in diagnostic images (c.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the Agfa Impax OT3000 software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries. The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can be shown to patients to explain the procedure they will undergo and to help them understand the pathology present. The application consists of the following components: - Hip Prosthetic Planning . - Knee Prosthetic Planning ● - Biometry Planning takes into account patient motion and metrics . - Coxometry tracking of known measurement values in pediatrics to determine surgical . intervention - Osteotomy determines optimum osteotomy locations . - Impax Diagnostic Workstation ●

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy. The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

The Drystar 5300 is a free-standing printer used to print diagnostic images on transparent film 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 Drystar 5300 is a dry process, B/W medical image printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer has one film input tray, which can contain either 11x14 or 14x17 film. The printer is a networkonly printer.

The Drystar 5500 is a free-standing printer used to print diagnostic images on transparent film 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 Drystar 5500 is a dry-process, B/W printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer has two film input trays and each can accept any of five sizes of film, 8x10, 10x12, 11x14, 14x14, and 14x17. Film may be loaded in full daylight. The printer is a network-only printer. The resolution of both the Drystar 4500 and 5500 is 506 dpi. The print head in the Drystar 5500 is 14 inches wide (compared to 10 inches in the 4500), which with constant resolution means more pixels per line for the 5500. The film for the Drystar 5500, DT2 B/C, allows for faster printing (up to 180 films per minute for the largest size film) than the TM1 B/C used with the Drystar 4500.