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Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information. The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment. It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.

The new device is nearly identical to the Agfa predicate (OT-3000). It includes tools for performing common hip, knee and spine measurements, and provides access to orthopedic device manufacturers electronic templates. The measurements and tools enable planning of orthopedic procedures, monitoring patient progress and patient communications. The orthopedic application is compatible with multiple workstations and Impax® software versions. User may purchase a complete set of tools or individual modules depending on their needs. The basic principles of operation of the new and predicate devices are the same.

The system is indicated for the storage, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from any DICOM device by healthcare professionals, including radiologists, physicians, technologists and clinicians. - With the Teleradiology option it can be used to consult and share information with remote users. - With the Mammography option it can be used for screening and diagnosis (with MG, "For presentation" images only) from FDA approved modalities in softcopy and printed formats. - With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine (Coxometry, Gonometry, Lipman Cobb). - With the Slice Imaging option it can be used to process basic 3D rendering: MIP, MPR or series synchronization. - With the Quality Assurance option it can be used by PACS administrators or technologists to perform quality control activities related to patient images and data.

The new device is a multifunction PACS workstation for displaying and interpretation of medical images. It includes functions similar to the predicates. It can be used as a general radiography or orthopedic workstation. It displays "for presentation" (MG) mammography images. Image processing is handled by the mammography modalities. It can also display 3D images acquired from CT and MR modalities. It provides user teleradiology functionalities to share information and consult with remote users and can be used to perform quality control activities related to patient images and data.

Agfa's Computed Radiography Systems with NX 2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton "in luding 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 musculoskelelal regions of adult or pediatric patients. Agfa's Computed Radiography Systems with NX 2.X software are not indicated for use in mammography.

The predicate and new devices are nearly identical computed radiography imaging systems. NX 2.X systems (new devices) have: - . An improved image processing package, Musica2 Platinum (optional). provides improved image processing of the thorax, abdomen or musculoskeletal images for adult or pediatric patients. - . An auto-stitch function that allows users to automatically combine subimages of large patient anatomies (a leg or spine, for example) into a single image. - The ability to designate one workstation as the central workstation that . has the ability to view exams on all connected workstations. The basic principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.