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The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The MrJ 3300 is a magnetic resonance imaging device characterized by an open structure to minize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics. It is indicated for use as a diagnostic imaging device that produces transverse, sagittal. coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot; shoulder, elbow, wrist; hand, calf, thigh, arm, forearm. Temporo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). .... The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can vield information that can be useful in the determination of a diagnosis. ... . The MrJ 3300 has a 0,3 T magnet, which has a higher intensity than the predicate one (0,2T). Of course the new 0,3 T magnet with slightly different dimensions needs a new design of covers and some modest upgrades due to design ageing of the MrJ Inspire 01-2000-01 product. New covers of the system have been designed by the same company which designed MRJ Inspire's covers and they have been manufactured using the same C-UL-US approved fire protection materials. The MrJ 3300 employs both the positioning LED (K033507) and the positioning touch screen . (K100164) to give to the user the maximum chances to get rapidly to the correct patient of positioning. The scanning sequences are the same employed in MrJ Inspire model (K100164) unless the FLAIR sequences which are equivalent to the same FLAIR sequences employed on the MrOpen 05 T K101295 device. The MrJ 3300 is furnished with the Performance Package of new concept receiving coils . (code 06-0096-00) equivalent to the Performance Package K121249.

The intended use of the Performance package is to enable the permanent magnet based MRI systems designed by Paramed (MrJ and MrJ Inspire) to perform MR scan of the following districts: C-Spine one dedicated coil (code 01-2023), L-Spine two sizes of dedicated coils (codes 01-2021 and 01-2022), all other joints using a linear single channel coil named MP wrap (code 01-2024) which is not aimed to specific districts but can fit most joints (such as, for instance, knee, foot, ankle, elbow, wrist, hand ... ). The Performance package inherits the same limitations of the System to which it is applied which is: only joint pathologies ( no tumor, no angiography). The Performance package enables the MRI System to which it is applied to acquire images of the districts being diagnosed in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The Performance Package for MrJ series (MrJ and MRJ Inpsire) permanent magnet based MRI tomographs is a set of receiving coils intended to increase patient comfort while performing the same district examinations already performed by previously marketed receiving coils. The two here proposed Kits differ only for what regards the connector to the magnet which for MrJ is flat and for MrJ Inspire it is round. The components of the Performance Package (for MrJ and MRJ Inpsire) are the following: C-Spine dedicated coil, L-Spine dedicated coils (Small size and Large size), MP_wrap multipurpose coil. The Proposed coils are receive coils. The images produced by the device, when Performance Package is employed reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging. MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spinlattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The MrOpen 05 MRI system is substantially equivalent to Paramed MrOpen K073362 as a total body open structure superconducting MRI Scanner.

The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.

The MROpen is a total body magnetic resonance imaging device, It is indicated for use as a diagnostic total body imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (T), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The MROpen is a total body magnetic resonance imaging device

The intended use of Paramed's MRJ_Extended product is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, call, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C- spine and L-Spine with limitation to joint pathologies (no tumors, no anglography). The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation fime (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The MRJ Extended MRI system is substantially equivalent to the currently available Paramed MrJ cleared via K033507 for all items excluded the spine coils for which the and Esaote S-Scan system cleared via K063207 is addressed.

The intended use of Paramed's MRJ product is for diagnostic MRI imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ and cervical spine with limitation to joint pathologies -- no tumors, no angiography. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend on the MR parameters (spin-lattice relaxation time -- T1, spin-spin relaxation time -- T2, nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

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