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The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.

The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device also supports Dual Energy chest imaging. The Dual Energy feature is not to be used for imaging pediatric patients.

The DRX-Evolution Plus is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). In addition to general radiography applications, the system also includes the optional Dual Energy functionality. The DRX-Evolution Plus can be used with digital radiography (DR) and computed radiography (CR) receptors. "Smart" Features are added to the DRX-Evolution Plus system to provide remote exam set-up capabilities for existing functions of the DRX-Evolution Plus system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart" features, described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality.

The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography

The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Smart Features are added to the DRX-Compass system to provide remote capabilities for existing functions of the DRX-Compass system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart features", described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. These improvements are referred to as "smart features" in the product documentation. Implementation of these "smart features" does not change the intended use of the system.

The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient treatment areas.

The DRX-Rise Mobile X-ray System is a diagnostic mobile X-ray system utilizing digital radiography technology. The DRX-Rise consists of a self-contained X-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary X-ray room. These components are mounted on a motorized cart that is battery powered to enable the device to be driven from location to location by user interaction. The DRX-Rise system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The device acquires images using Carestream's clinical acquisition software platform (ImageView) and digital flat panel detectors. ImageView is considered software that is of Moderate Level of Concern and not intended for manipulation of medical images. The DRX-Rise Mobile X-ray System is designed for digital radiography (DR) with Carestream detectors.

The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications.

Eclipse software runs inside the Image View product application software (not considered stand-alone software). Smart Noise Cancellation is an optional feature (module) that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR). Eclipse II with Smart Noise Cancellation supports the Carestream DRX family of detectors which includes all CR and DR detectors. The Smart Noise Cancellation module consists of a Convolutional Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions. Eclipse II with Smart Noise Cancellation incorporates enhanced noise reduction prior to executing Eclipse image processing software. The software has the capability to lower dose up to 50% when processed through the Eclipse II software with SNC, resulting in improved image quality. A 50% dose reduction for CSI panel images and 40% dose reduction for GOS panel images when processed with Eclipse II and SNC results in image quality as good as or better than nominal dose images

The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications.

Eclipse software runs inside the ImageView product application software (also namely console software). The Eclipse image processing software II with Smart Noise Cancellation is similar to the predicate Eclipse image processing software (K180809). Eclipse with Smart Noise Cancellation is an optional feature that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Direct Radiography (DR). The modified software is considered an extension of the software (it is not stand alone and is to be used only with the predicate device supports the Carestream DRX family of detectors, this includes all CR and DR detectors. The primary difference between the predicate and the subject device is the addition of a Smart Noise Cancellation module. The Smart Noise Cancellation module consists of a Convolutional Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions. Eclipse with Smart Noise Cancellation (modified device) incorporates enhanced noise reduction prior to executing Eclipse II image processing software.

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 projections wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, and angiography applications

The modified DRX Plus 3543C is a scintillator-photodetector device (Solid State X-ray Imager) utilizing an amorphous silicon flat panel image sensor. The modified detector is redesigned with the intent to reduce weight and increase durability, while utilizing a non-glass substrate material and cesium iodide scintillator. The modified detector, like the predicate is designed to interact with Carestream's DRX-1 System (K090318). The modified DRX Plus 3543C Detector, like the predicate, creates a digital image from the x-rays incident on the input surface during an x-ray exposure. The flat panel imager absorbs incident x-rays and converts the energy into visible light photons. These light photons are converted into electrical charge and stored in structures called "pixels." The digital value in each pixel of the image is directly related to the intensity of the incident x-ray flux at that particular location on the surface of the detector. Image acquisition software is used to correct the digital image for defective pixels and lines on the detector, perform gain and offset correction and generate sub-sampled preview images

The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.

The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wallmounted image receptors/detectors for upright imaging, a ceiling mounted tube support, x-ray tube, and collimator (beam-limiting device). The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator. The modified (subject) device, DRX-Compass, is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows: - New marketing names DRX-Compass and DR-Fit will be used depending upon regional marketing strategies. - Implementation of a new wall stand that provides options for automated vertical motion and vertical to horizontal manual tilt (90 degrees). - Implementation of a different Overhead Tube Crane (OTC): This OTC is ceiling suspended and provides x-y movement capability for the tube head with respect to the detector. The tube head is capable of three options for alignment with the image acquisition device (detector) as follows: 1) manual alignment by moving the x-ray tube support, 2) manual alignment using the "tube-up/tube-down" switch on the tube support, or 3) automatic alignment using the "Auto Position" switch to activate motors on the tube support in x, y, z, and alpha directions - Focus 35C and Focus 43C Detectors are added as additional optional detector selections for customers ordering a DRX-Compass system. - X-Ray Generator: Several Carestream designed generators are available with the system depending on power requirements and regional configurations. These generators are functionally identical to the generators currently offered for sale with the Q-Rad System.

The Vita Flex CR System is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LL is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.

The Vita Flex CR System with LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy. The Vita Flex CR system with LLI accepts an x-ray cassette with a screen. An X-ray cassette is a light-resistant container that protects the screen from exposure to daylight, and allows the passage of X-rays through the front cover on to the phosphor layer of the screen. When stroked by radiation the intensifying screen fluoresces emitting a light that creates the image. Our Vita Flex CR system take a cassette as an input and it extracts an exposed screen and scans in the image off the screen. The image is stored on the computer system attached to the Vita Flex CR system. Once the scan is complete the screen data is erased and the screen is placed back inside the cassette to be used again by the customer. When a cassette is properly inserted into the scanner, the scanner will lock the cassette in place. Once locked into place the cassette door can be opened to allow the scanner to feed the screen into the unit. The operation of the scanning of the LLI cassette and screen will be done exactly as the predicate. Since the size of a long length imaging screen and cassette is large, the operation consists of 2 scans – scanning one half of the image, then turning the cassette around and scanning the second half of the image.

The Q-Rad Radiographic System is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography

The Q-Rad System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, tube supports (ceiling-suspended or floormounted), x-ray tube, and collimator (beam-limiting device). The Q-Rad System can be used with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator. The modified (subject) device is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows: - Integration of the FDA-Cleared ImageView Software (K163203) with the Q-Rad ● System. - A circuit board (CIB+ Board) has been implemented on the Q-Rad System to ● facilitate a new communication protocol between the ImageView Software and the generator. - The QMI (Quantum Medical Imaging) high voltage generator has been replaced with a Carestream-designed high voltage generator. - The VacuTec Dose Area Product (DAP) meter Model 1560015 has been replaced ● with an equivalent DAP from a different supplier, the IBA Kermax plus with Ethernet interface 120-131 ETH (Standard Size). - The Generator Control Box has been replaced. This control box is used to switch ● the generator on and off. Changes to the control box are cosmetic only and do not impact its functionality.