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The PoleStar system is a magnetic resonance diagnostic device intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic resonance spectra, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. The StarShield V3 is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.

The StarShieldV3 is an accessory of Odin's PoleStar Intraoperative Magnetic Resonance system. It is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent, required Elootromagnotion The RF Tent is a portable modular structure that consist of four principal components: - The foldable frame . - The cover . - The control unit . - The floor . The RF Tent is not connected to the PoleStar gantry or the OR table.

The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. Anatomical regions: extremities and selected sections of the head. Nuclei excited: H-1 Diagnostic uses: T1, T2, T2* and density weighted imaging. The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.

The PoleStar N-20 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The PoleStar N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.

The RF Tent is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar N-10 (K002242).

To acquire high-quality MR images. it is necessary to isolate the MRI scanner from external sources of EMI (Electromagnetic Interference). Generally, copper sheeting is installed in the OR walls to isolate the OR from external interference. This solution is relatively expensive, and also requires the OR to be out of use during the installation process. Once the copper sheeting is installed, all procedures involving the PoleStar N-10 intraoperative MRI must be performed in the dedicated shielded room. The RF Tent presented in this premarket notification expands the capability of the PoleStar N-10 (K002242), by providing a low cost, simple and effective alternative to the fixed copper shielding. Because it is portable, it also allows the PoleStar N-10 to be used in more than a single dedicated OR. Thereby increasing the flexibility of the use of the system.

A magnetic resonance diagnostic device is intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic resonance spectra, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System (K002242). It improves imaging of selected sections of the head and extremities.

The FlexiCoil is a malleable receive-only surface coil intended to facilitate intraoperative MR imaging of selected sections of the head and extremities. This component is a malleable circular enclosed coil that consists of copper straps covered with Medical Foam Tape and an electronic tuning box, which can be placed around the anatomy of interest for MR imaging. The malleable structure of the coil allows adjustment of size and shape by pulling/releasing the plastic holders on both sides of the coil, providing the highest possible contact between the coil and the area to be imaged. Due to its malleability the FlexiCoil can cover a wider area than the presently used coils (K991243) resulting in better image uniformity and a better overall SNR when imaging structures near the surface of the patient's head or extremity. The improved SNR is a result of the coil being closer to the signal-emitting anatomy, and being fully tuned and matched to the signal and receive channel. In addition the coil can be easily placed near the anatomy to be imaged with little or no patient post procedure discomfort. The FlexiCoil is for single use only and is supplied non-sterile.