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Radiography of the breast Preoperative wire localization and stereotactic biopsy procedures

The Advanced Automatic Detector Selection (AADS) option is used with the automatic exposure control of the GLORY mammography system. With the AADS option, the legally marketed GLORY system can determine exposure parameters automatically from a detector located beneath the densest breast tissue.

Whole body computerized tomography.

The Volumax is a continuous rotation CT scanner consisting of a gantry, patient table, operator station and accessories. Its main characteristics are: - Continuous rotation and Helix (spiral) scanning. . - Simultaneous multi-slice scanning. . - Minimum scan time of 0.3 second. . - Minimum reconstruction time of 0.5 second. .

Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.

The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included. The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.

MAGNETIC RESONANCE IMAGINE BODY WHOLE

The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation.

The production of a series of images of the heart at different phases of the cardiac cycle.

The modification is a cardiac gating technique referred to as Retrospective Gating. In standard cardiac gating, the acquisition is triggered by the QRS pulse of the ECG. In Retrospective Gating, the scan runs continuously, and the correlation with the QRS cycle is done after the fact. This modification does not involve any changes to the existing hardware of the predicate devices.

Magnetic Resonance Imaging of small extremity joints.

The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (k944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems.

Radiography of the breast

The GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381). Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.

Whole Body Magnet Resonance Imaging

The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.

Cardiac scoring from whole body computed tomography derived measurements

The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.

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The current modification to the Gyrex 2T-Prestige consists of the addition of software to enable the production of 'H spectra are produced using the existing MRI hardware. The spectroscopy software includes automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction and display, and higher level spectral processing functions.