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DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD V1.0 supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MRI data sets. DynaCAD also provides an intervention planning tool (DynaLOC) which assists with MRI guidance of percutaneous interventional procedures. When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues. Patient management decisions should not be made based solely on the results of DynaCAD analysis.

DynaCAD image analysis relies on the assumption that pixels having similar MRI signal intensities represent similar tissues. The DynaCAD software simultaneously analyzes the pixel signal intensities from multiple MRI sequences and applies parametric fitting methods to perform tissue segmentation and classification. The DynaCAD system consists of proprietary software developed by MRI Devices Corporation which is installed on an off-the-shelf personal computer and a monitor configured as a DynaCAD display station.

To be used in conjunction with a Magnetic Resonance Scanner to: - 1) Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician. - 2) Permit MR-quided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Model BBC-127 Biopsy Breast Coil

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.

Model HNC-127-INT Neurovascular Array Coil

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

Model HRW-127 Wrist Array Coil

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder when interpreted by a trained physician.

Model QSC-127-INT Shoulder Array Coil Set

The ClipLoc™ Soft Tissue Marker is indicated for use to radiographically and radiologically mark the surgical location in breast or other soft tissue following an open or percutaneous procedure. It is intended to attach to soft tissue, including breast tissue, at the surgical site during an open or percutaneous procedure.

The ClipLoc Soft Tissue Marker is a sterile, single patient use device comprised of a small nickeltitanium marker (clip), a well as a disposable introducer and applier. The introducer is a coaxial cannula with a beveled tip and a molded hub. The ClipLoc is preloaded near the distal end of the cannula. The applier is a stylette with a cap. A plastic safety connector holds the applier and introducer needle in the appropriate position ("Ready") and helps prevent premature deployment of the marker. After removal of the safety connector, the ClipLoc is deployed by manually advancing the needle. The ClipLoc may be used with either visual or imaging guidance (such as ultrasound, X-Ray, stereotaxy, or Magnetic Resonance). It may be used directly, or applied through another coaxial needle or guide associated with percutaneous biopsy. The entire system including ClipLoc, introducer, and applier is Magnetic Resonance (MR) safe and compatible up to and including 1.5 Tesla magnetic field strength. The marker, when present in a patient undergoing an MR exam at 3.0 Tesla or less, will not create additional hazard or risk with respect to magnetic field-related interactions, movement, gradient stimulation or heating.

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

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To be used in conjunction with a Magnetic Resonance Scanner to: 1) Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician. 2) Permit MR-guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Not Found

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the Knee, Foot, and Ankle that can be interpreted by a trained physician.

Model KFA-12 Knee, Foot, and Ankle Array Coil

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.

Model HAC-12 and HAC-30 Head Array Coil