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1. Intended to be used as a universal diaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. 2. Intended for use by a qualified/trained doctor or technologist on both and pediatric subjects taking diagnostic and fluoroscopic exposures of the whole body, skull, spinal column, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in prone or supine position.

The main function of the KALARE (DREX-KL80) is to perform fluoroscopy/radiography of the examinations of the gastrointestinal tract examination, support for endoscopy, nonvascular contrast study, general abdominal radiography and general skeletal radiography. Using fluorescent scintillation effects of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis and treatment.

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.

The APLIO ARTIDA, Model SSH-880CV is a mobile diagnostic ultrasound system. This is a Track 3 device that employs a wide array of probes including convex, pencil, flat linear array and sector array, with a frequency range of approximately 2.0 MHz to 7.5 MHz. This system supports basic measurements including distance, time, angle, and trace, as well as combinations of some basic measurements.

The Angio Workstation is used in combination with an interventional angiography system (Infinix-i series systems and INFX-8000V and INFX-8000C systems) to provide 2D and 3D imaging and Dose Tracking System functions in selective catheter angiography for the heart, chest, and abdomen.

The XIDF-AWS801 Angio Workstatoin is a workstation for post-processing software that displays images in 2-d or 3-d format to provide additional information to the clinician. The software on this device remains unchanged with the exception of XIDF-DTS802 software. The dose tracking system (DTS) is an application software package intended to provide the estimated dose distribution information during radiographic and fluoroscopic procedures. The dose tracking system (DTS) calculates the radiation dose of the patient's skin using the exposure technique parameters and exposure geometry obtained from the x-ray imaging system and presents the cumulative results in a color mapping on a 3D graphic of the patient model.

This software is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.

UltraExtend USWS-900A v2.1 and v3.1 is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound systems (Aplio XG, Aplio MX, Aplio Artida, Aplio 300, Aplio 400 and Aplio 500), to be loaded onto a PC for image processing with other application software product. UltraExtend USWS-900A v2.1 and v3.1 is a postprocessing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system the data was acquired from, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC.

DTS is intended to display an approximation of both skin dose distribution and skin dose rate in real time during fluoroscopic interventional procedures of cardiac angiography. This software is intended for use on the Toshiba INFX-8000F CSi cardiac labs.

The dose tracking system (DTS) is an application software package intended to provide the estimated dose distribution information during X-ray fluoroscopic procedures. The dose tracking system (DTS) calculates the radiation dose of the patient's skin using the exposure technique parameters and exposure geometry obtained from the x-ray imaging system (Toshiba Infinix-i) and presents the cumulative results in a color mapping on a 3D graphic of the patient model.

The MRI system is indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are: - Proton density (PD) (also called hydrogen density), - Spin-lattice relaxation time (T1), - Spin-spin relaxation time (T2), - Flow dynamics, - Chemical shift. Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Titan with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using. the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).

The UltraExtend FX (TUW-U001S) is designed to allow the user to observe images and perform analysis using the examination data acquired with specified diagnostic ultrasound systems Aplio 500, Aplio 400 and Aplio 300.

UltraExtend FX is a software package that can be installed in a general-purpose personal computer (PC) to enable data acquired from Aplio diagnostic ultrasound system (Aplio 300, Aplio 400 and Aplio 500), to be loaded onto the PC for image processing with other application software product. UltraExtend FX is a post-processing software that implements functionality and operability equivalent to that of the diagnostic ultrasound system, providing a seamless image reading environment from examination using the diagnostic ultrasound system to diagnosis using the PC.

This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.

The RADREX-i is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals shich can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto stitching function.

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

The Aquilion ONE Vision, TSX-301C/1, v4.90 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

Acquisition and display of axial x-ray images of the whole body to include the head.

The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.