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Vantage Titan 3T systems are 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. Additionally, this system is capable of non-contrast enhanced imaging, such as 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 (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K152371. This system is based upon the technology, software and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

SURESubtraction Lung software is intended to aid in the visualization of lung parenchyma enhancement by subtracting a non-contrast enhanced volume from a contrast enhanced volume.

The SURESubtraction Lung, CSSL-001A, is a post-processing software that subtracts image information by comparison of two data sets, one of which is contrast enhanced. Registration software is used to match the two independent studies.

The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest. The MJAH-167A is intended to be used on a Toshiba 1.5T MR System

The Octave SPEEDER Head is a receive-only phased Array Coil that can receive NMR signal from head, cervical region and upper chest. The coil consists two parts of a head base, a removable anterior coil. The head base includes 7 coil elements, which are divided into 3 sections. The removable anterior coil includes 4 coil elements, which are divided into 2 sections: Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine. The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis for cardiac and vascular. 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. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Abdominal, Small Organ (Specify) (1), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

The APLIO ARTIDA SSH-880CV is a mobile Ultrasound Diagnostic System for cardiology and vascular imaging. It has a capability of providing a 3D real time image of a heart as well as 2D images. The system is consists of a main console, a color LCD display and several transducers. The compatible transducers are linear array, curved linear and phased array with a frequency range of 2.5 MHz to 7.5MHz. Accordingly it has various software options for cardiac and vascular examinations.

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 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 TSX-301B 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.

This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.

Vantage Titan 3T systems are 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. Additionally, this system is capable of non-contrast enhanced imaging, such as 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 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm. The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications. - . Field strength of magnet has been changed to 3T. - . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz). - . Number of RF amplifier channels is increased from 1 to 2. - Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. . - Software platform has been changed. .