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The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projection exams. The system consists of a high voltage x-ray generator, overhead tube crane with x-ray tube assembly, radiographic table with detector tray, Bucky image receptor on an upright wall stand, and x-ray controls containing a power distribution unit and operator PC (user interface).

The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR. DR, CT, MR, NM and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography.

CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. It is a software only solution that contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians. Vue PACS provides functionality to allow remote site access to image and patient data enabling diagnostic reading through industry standard interfaces. It is designed using an open architecture that allows for various proprietary and off the shelf software components to be integrated with off the shelf hardware components and configured meeting the user's specific needs in a single-site or multi-site environment. CARESTREAM Vue Motion is a Light Viewer designed to provide wireless and portable access to medical images for remote reading or referral purposes from web browsers including enterprise distribution of the radiology images and related data. The needs to provide real time imaging results and imaging related data to the enterprise users' commands that imaging solutions have a simple distribution mechanism through simple and broadly used technology. The patient portfolio is made available to physicians from their offices within their EMR. from home on local PC's or remotely through tablet and other devices. With integration into EMR systems, Vue Motion helps hospital users and healthcare facilities enhance patient care, by bringing the complete patient imaging record and supporting data into the healthcare enterprise. Image storage, viewing and distribution becomes a seamless part of the EMR. A "patient search page", including smart Google-like search capabilities is also available for users that have no local EMR/HIS integration. Vue Motion is offered as an option for the PACS, Vue Archive (onsite or via Vue Cloud) or The Carestream Vendor Neutral Archive and provides a zero footprint imaging viewer that can be deployed on the fly and accessible by the right user from anywhere, over virtually any operating system or over virtually any browser enabled device. The software technology uses HTML5 which allows any browser enabled device to run the software application. CARESTREAM Vue Motion has a simpler GUI for viewing including zoom, pan, windowing, basic measurements, cine etc. It works on any operating system and with virtually any browser enabled device such as PC's, iPad, mobiles etc. It is selfdeployable and performs well over low bandwidth networks. It supports collaboration with other users through the sticky notes mechanism.

The device is intended to capture for display radiographic images of human anatomy including both pediatric and adult patients. The device is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications.

The Carestream DRX-1 System is a diagnostic imaging system utilizing digital radiography (DR) technology that is used with diagnostic x-ray systems. The system consists of the Carestream DRX-1 System Console (operator console), flat panel digital imager (detector), and optional tether interface box. The system can operate with either the Carestream DRX-1 System Detector (GOS) or the DRX-2530C Detector (Csl) and can be configured to register and use both detectors. Images captured with the flat panel digital detector can be communicated to the operator console via tethered or wireless connection.

The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

The Carestream CR Mammography Cassette with SNP-M1 Screen is a structured needle phosphor detector used in conjunction with the Kodak DirectView CR Mammography Feature on Kodak DirectView CR Systems for generating digital mammographic images. The Carestream CR Mammography Cassette SNP-M1 Screen is used in the same manner as a traditional screen-film cassette when performing radiographic patient exposures and will be used in the DirectView CR Systems: CR850, readers problem on on and Elite CR readers using the Kodak DirectView CR Mammography Feature.

The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries. It is also indicated for use in viewing and capturing intraoral color video images for the purpose of: - Allowing practitioners to view and magnify all regions of the oral cavity - Assisting in communication with the patient by providing a view of treatment areas before and after a procedure - Providing images for documentation in patient records.

The CS 1600 Intraoral Camera (CS 1600) is an intraoral camera system that also includes an optical caries detection system based on fluorescence imaging with reflectance enhancement. The system is intended for use by healthcare professionals in dental and dental sub-specialty clinical settings. The system consists of an intraoral camera assembly which is connected via USB connection to a PC, and associated image acquisition software and accessories. Accessories include hygienic barrier sheaths and a collar attachment for the camera assembly that is used for maintaining an optimal working distance in either caries detection mode.

The DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital imaging source output signals. The device is intended for use with DRYVIEW CHROMA film and reflective media. The device will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging). The images are to be used for medical diagnosis and referral to physicians and their patients. The DRYVIEW CHROMA Imaging System is not intended for use with FFDM or CR Mammography systems.

The DRYVIEW CHROMA Imaging System is an inkjet printing system. The DRYVIEW CHROMA Imaging System (CHROMA System) receives medical data including image and clinical report data from a digital modality. This data is received from medical image source devices (modalities) over a network and communicated to the CHROMA device via digital communication standard, DICOM. User control is performed directly by the modality or through the host control. The CHROMA System device prints the information received using piezoelectric inkjet technology. Tiny ink droplets are propelled from pizeoelectric nozzles in inige toenhology. " in media to form the image or report communicated by the digital modality. The CHROMA System device prints on transparent polyester based (film) as well as reflective (paper) media. Media is removed from a cartridge and transported into the CHROMA System device. Print data and media merge within the device. The CHROMA System employs the use of test patterns to verify imaging performance. A test pattern generator is incorporated to assure consistency between input signals and output density. Software is used to control the image management and machine functions. The information sent to the DICOM interface is used by the DICOM Interface to choose the correct set of printing parameters and halftone patterns for optimal image quality.

for the indications for use stated in the enclosure

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