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Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and obligue orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging.

MROpen Evo is a whole body magnetic resonance diagnostic medical device that acquires high-resolution medical images of various parts of the body. In particular, it produces images of the entire body except: upper abdomen, heart, lungs and breasts with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence. The standard composition of the MROpen Evo device is: Magnetic Unit Operator PC- Operator PC - Electronic Cabinet - Penetration Filters - Major Software MR GUI-PRO 3.1. Coil set (Body MAX, Hand MAX, Cervical MAX, Knee MAX, Multipurpose Linear, Flat Flex, Spine, Head-Neck, Long Spine, Shoulder) Cushions' Set The device consists of two models. 03-2000-00. The 03-4000-00 model of the MROpen Evo device has a very similar composition to the 03-2000-00 model, but most of the subassemblies that constitute it are replaced with others of equal functionality, in order to reduce production costs. The MROpen Evo device allows the execution of standing imaging for those cases that require this need or facilitates acquisitions on patients suffering from movement disorders or suffering from claustrophobia. It is also possible to undergo this investigation in patients who have a high weight, but in any case, not exceeding 200 kg. The software called MR GU-PRO represents the set of SW modules necessary for the MROpen Evo MR scanner based on the I-box spectrometer. The main modules act as a graphic interface for the execution of the exam. The MR GUI-PRO software has external interface elements, on the one hand the operator who interacts via monitor, keyboard and mouse and the other HW modules of the system and mainly: Gradient Amplifier, RF reception signal amplifier.

MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position. 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 (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.

Like the previously cleared device K190524, the actual MRopen EVO is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV. Modification of K190524 cleared device. - . New commercial name (hence labeling is amended) - . Different cover colours from light blue to grey - . Changes in labelling due to above changes MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. 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 (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 MRI diagnostic Device is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images display the internal structure of the body regions for which it is indicated (shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, 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 (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 Upgrade Kit MR GUI PRO is a kit containing HW and SW to upgrade previously cleared installed models (K033507, K100164, K122034) to the state of the art. MrJ 3300 Plus is the commercial name of the same Upgrade Kit when integrated in factory on newly manufactured K122034+this change. The modification introduces an internally developed User Interface 0 and upgrades computer/spectrometer hardware to the state of the art to run user interface 0. The produced images will still 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 (TI), spin-spin relaxation time (T2), chemical shift and flow velocity.

MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. 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 yield information that can be useful in the determination of a diagnosis.

Like the previously cleared device K151466, the actual MRopen 0.5 T is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV. Modification of K151466 cleared device. - Introduce DWI technique based on HASTE readout sequence 0 - Introduce internally developed User Interface 0 - Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA - 0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils) - Long Spine receiving coil o - 0 Shoulder coil new model - Changes to patient support shapes and courtesy cushions o MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. 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 (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 modification reflected in this Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table.