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This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

The digital radiography SKR 3000 performs X-ray imaging of the human body using an X-ray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data. - This device is not intended for use in mammography - This device is also used for carrying out exposures on children. The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. The CS-7 is a software with basic documentation level. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation correction (Intelligent-Grid). The Intelligent-Grid is cleared in K151465. The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection. The SKR 3000 is distributed under a commercial name AeroDR 3. The purpose of the current premarket submission is to add pediatric use indications for the SKR 3000 imaging system.

Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR is used to acquire/Process/Display/Store/Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screener CR system is used. Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.

The Wireless/ Wired X-Ray Flat Panel Detectors are designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (CsI). The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission. Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR", runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes: 1. User Login 2. Display Connectivity status of hardware devices like detector 3. Patient entry (Manual, Emergency and Worklist) 4. Exam entry 5. Image processing 6. Search patient Data 7. Print DICOM Image 8. Exit

EXPD 114, EXPD 114P, EXPD 114G, EXPD 114PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. It is intended for both adult and pediatric populations.

EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG are flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form. EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG are indirect conversion devices in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta. The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients. It is not intended for use in mammography.

In comparison to existing devices, the new detectors incorporate a Flexible a-Si in the TFT material within the panel. The primary difference from the conventional glass a-Si panel is that the electronic circuits, such as silicon, are deposited on a plastic substrate instead of a glass substrate during the manufacturing of the TFT panel. Since only the material of the substrate on which the silicon is deposited changes, the overall image performance remains unaffected. Another difference is the pixel pitch. While existing products feature only a pixel pitch of 140μm, the new models include an option with a pixel pitch of 100um. The resolution of an X-ray detector has a significant impact on MTF (Modulation Transfer Function) and sensitivity.

Radlink GPS Pro Imaging is an image-processing software intended to assist in hip procedures by measuring the acetabulum's position relative to local bone structures identified from radiological images. The device allows for overlaying digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

The Radlink® GPS Pro Imaging is an image processing software designed to assist orthopedic surgeons in positioning hip, knee, and trauma components. The software leverages advanced geographic measurement and stitching technologies, which have been previously FDA cleared, ensuring precise and reliable image handling. These foundational technologies continue to be the primary features of software. Additionally, Radlink GPS Pro Imaging software supports complete image acquisition and DICOM transmission capabilities, facilitating seamless integration with existing hospital systems. It is compatible with Windows operating system, and requires minimal hardware specifications, making it a versatile solution for different clinical setups.

Lux HD 35 Detector and Lux HD 43 Detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. Lux HD 35 Detector and Lux HD 43 Detector are not intended for mammography or dental applications.

Lux HD 35 Detector and Lux HD 43 Detector are digital flat panel detector. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm (Lux HD 35 Detector)/42.67cm × 42.67cm (Lux HD 43 Detector) .The differences between two models are overall change in the dimensions of the image receptor. The sensor plate of Lux HD 35 Detector and Lux HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Lux HD 35 Detector and Lux HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system. The Digital Radiographic Imaging Acquisition Software Platform - DR is part of the system, it is used to acquire, enhance, view image from Lux HD 35 Detector and Lux HD 43 Detector.

The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The Exam Vue Apex flat panel x-ray detector system is not indicated for use in mammography.

The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are: EVA 14W, with a 14x17in (35x43cm) wireless cassette sized panel EVA 17W, with a 17x17in (43x43cm) wireless cassette sized panel EVA 10W, with a 10x12 (24x30cm) wireless cassette sized panel

The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.

The GXR Series Diagnostic X-ray System consists of a combination of an x-ray generator, and associated equipment such as tube stand, patient table, and, digital imaging system.

The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals.

The Digital Radiography X-ray System is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs. Software is of Basic level of concern, which is also based on a predicate device.

INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use.

INNOVISION-EXII can receive X-ray signals from X-ray irradiation and digitize them into X-ray images by converting digital images to DICOM image format using Elui imaging software. INNOVISION-EXII is a general radiography X-ray system and not for mammography nor fluoroscopy. In addition, the system must be operated by a user who is trained and licensed to handle a general radiography X-ray system to meet the regulatory requirements of a Radiologic Technologist. Target areas for examinations include the head, spine, chest, and abdomen for diagnostic screening of orthopedic, respiratory, or vertebral discs. The system can capture a patient's postures, such as sitting, standing, or lying. This system can be used for patients of all ages, but it should be used with care for pregnant women and infants. The INNOVISION-EXII system has no part directly touching the patient's body.