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The IMPAX MA3000 Diagnostic PACS Workstation is 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 IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images. The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.

IMPAX MA3000 is a diagnostic softcopy breast imaging workstation with diagnostic print capability. The following features are available: · Display and printing of regionally approved DICOM DR Digital Mammography Images (MG SOP class) · Display and printing of regionally approved DICOM CR Digital Mammography Images (CR SOP class) The Hardware configuration of Embrace™ will consist of the following: Dell Precision™ Workstation 650; System (Per Host Machine): 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 10/100/1000 Ethernet adapter Power Supplies: Default Chassis: Tower Peripherals: Microsoft IntelliMouse or IntelliMouse 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)

Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis. The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control. When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients. Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.

The predicate and new devices are nearly identical computed radiography imaging systems. NX 2008 systems (new devices) have updated hardware and software that offers: - An optional medical grade display. The display is cleared separately . by the display manufacturer. - The capability to operate as a mixed-use system for both general . radiography and mammography (where approved or licensed). This is not the case for the USA the separately licensed mammography system is not available. - Improved tools for installation, configuration and management. . - The ability to receive DICOM veterinary images and data. . The basic principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.

Registration and Fusion (Basic and Extended) is indicated for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.

Medical Data Registration and Fusion R 1.0 is a PACS plug-in (accessory). It is an image analysis software package that establishes the geometrical relationship between different DICOM 3.0 compliant 3-D medical data sets from PET, MR and CT imaging (registration"). The matched images are displayed (fusion') by either the use of semitransparent overlays or by displaying them side-by-side. Registration and fusion facilitates the comparison of PET/CT, PET/MRI, CT/CT, MRI/MRI, CT/MRI image data sets for use in: The general radiology department for various lesions. The oncology department for various cancerous lesions. The neurology department for various lesions. The rigid registration used in the application, aims to help the clinician navigate to the same anatomical location in both image sets. The Medical Data Registration and Fusion software runs on Agfa's PACS workstations (Impax 5.3 and 6.3 workstations).

OrthoGon is a pluq-in software application for PACS workstations. The package is indicated to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid in the diagnosis of disorders and deformities. OrthoGon is intended for use in the fields of musculoskeletal radiology. orthopedics, traumatology and pediatrics using 2D X-ray images based on DICOM standards. The application is intended for use by radiologists, radiographers, technologists, referring physicians and orthopedic surgeons and can be used in operating theaters, mobile and military environments.

OrthoGon assists physicians in their analysis of anatomy and pathology by providing easy to use, interactive measurement schemes. OrthoGon allows the user to easily perform standard measurements and to compare results to prior measurements and to normal values from the medical literature. OrthoGon uses X-ray images based on the DICOM standards. The device is compatible with multiple PACS workstations and software versions. OrthoGon allows the user export results into Excel formatted reports.

The Drystar AXYS is a free-standing dry film 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, including digital mammography. The Drystar AXYS is a free standing device used to print diagnostic conventional and mammography 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 device is the new Drystar AXYS and it is a dry, B/W printer, using the direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets which can be viewed on a light box. The printer is sold with two film input trays. Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M. The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film in order to provide a wider range of optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images.