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The Wireless (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.

The subject device Yushan X-Ray Flat Panel Detector, model V14C, V14G, V17C, V17G, F14C, F14G are portable(wireless/wired) detectors, while V17Ce, V17Ge are a non-portable(wired) detector. The Yushan X-Ray Flat Panel Detector is 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. 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. Yushan series is working by using Xresta and DR console. The Xresta is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function includes: - 1. Detector status update - 2. Xray exposure workflow - 3. Image viewer and measurement. - 4. Post image process and DICOM file I/O - 5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network The DR Console is a software/app-based device, which is a software itself. When this app is operating the OTS can be considered as the iOS system (iOS 16 or above), the safety and effectiveness of this OTS has been assessed and evaluated through the software testing (compatibility) action and also the usability test (summative evaluation). All the functions operate normally and successfully under this OTS framework. The function includes: - 1. Imaging procedure review - 2. Worklist settings - 3. Detector connection settings - 4. Calibration - 5. Image processing

The Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.

InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V17Ce is a nonprotable(wired) digital detector. The Yushan X-Ray Flat Panel Detector with DROC is 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. V17Ce 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. The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and the scintillator material is cesium iodide (Csl). The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. 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. Yushan series is working by using DROC(Digital Radiography Operating Console). The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include: 1. Detector status update 2. Xray exposure workflow 3. Image viewer and measurement. 4. Post image process and DICOM file I/O 5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network.

The Wireless/Wired Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, fluoroscopy, tomography, and angiography applications.

InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model F14C, F14G are portable digital detector system. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model F14C, F14G support both wireless and wired/tethered data communication between the detector and the system. 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. Every model have memory exposure mode, and extended image readout feature. Additionally, roundededge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (CsI)). The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. 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. Yushan series is working by using DROC(Digital Radiography Operating Console). The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include: - 1. Detector status update - 2. Xray exposure workflow - 3. Image viewer and measurement. - 4. Post image process and DICOM file I/O - 5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

The Wireless(V14C, V14G, V17C, V17G)/Wired(V14C, V14G, V17C, V17G, V17Ge) Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, tomography, and angiography applications.

InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model V14C, V14G, V17C, V17G are portable digital detector system, while V17Ge is a non-protable digital detector. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model V14C, V14G, V17C, V17G support both wireless and wired/tethered data communication between the detector and the system, while model V17Ge is only applicable for wired use. 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. Every model 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. The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (CsI)). The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. 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. Yushan series is working due to the combination of SDK(software development kit) and DROC(Digital Radiography Operating Console). The SDK provides the interface for DROC to control the Yushan X-Ray Flat Panel Detector. SDK initiates the taking of X-ray images from the Yushan X-Ray Flat Panel Detector, through the Sensor Driver application. Once an X-ray is taken, Sensor Driver reads it from the flat panel and transfers it to SDK. Then the DROC will take the image data from SDK for further image process and display. The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include: - 1. Detector status update - 2. Xray exposure workflow - 3. Image viewer and measurement. - 4. Post image process and DICOM file I/O - 5. Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network

The Wireless/Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications.

InnoCare's Yushan X-Ray Flat Panel Detector (Yushan V14C, Yushan V14G) is a portable digital detector system. The Yushan X-Ray Flat Panel Detector is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults. The detector models support both wireless and wired/tethered data communication between the detector and the system. 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. The Yushan X-Ray Flat Panel Detector is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)). The Yushan X-Ray Flat Panel Detector sensor can automatically collects x-ray images from an x-ray source. The Yushan X-Ray Flat Panel Detector sensor collects xrays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. 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 SDK(software development kit) software library runs on a PC workstation and provides the interface for system manufacturer to control the Yushan X-Ray Flat Panel Detector. SDK initiates the taking of X-ray images from the Yushan X-Ray Flat Panel Detector, through the Sensor Driver application. Once an X-ray is taken, Sensor Driver reads it from the flat panel and transfers it to SDK. Then the user interface which designed by the system manufacture will take the image data from SDK for further image process and display.