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The Wireless(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC)/Wired(V14 CLARITY, V14 HC, V17 CLARITY, V17 HC, F14 CLARITY, F14 HC, W17 Clarity, W17 HC) PRORAD 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 PRORAD X-Ray Flat Panel Detector with DROC is not intended for mammography, 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.

PRORAD X-Ray Flat Panel Detector with DROC is the similar product to the predicate, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission, V14 Clarity, V14 HC, V17 Clarity, V17 HC, W17 HC, F14 Clarity, F14 HC, W17 Clarity are a portable(wireless)/nonportable(wired) digital detector. The PRORAD 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. 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. The PRORAD 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. PRORAD series is working by using DROC. This 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

ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly. The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.