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The Promaxo Magnetic Resonance Imaging (MRI) System II is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR quidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.

The Promaxo MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view.

The Promaxo Magnetic Resonance Imaging (MRI) System is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR guidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and a 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.

Promaxo's MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view. Promaxo MRI System's technological features are substantially equivalent to its predicate device. Both of them: - Are comprised of a magnet, magnet enclosure, electromagnetic gradient coils, RF transmission coil, and RF receiver coil - Have the main magnet comprised of an array of permanent magnets - Measure spatial distribution of protons exhibiting magnetic resonance - Are capable of imaging T1, T2, and Diffusion-Weighted Imaging - Are cryogen free - Provide an interactive user interface to operate the device - Promaxo's MRI system differs in technology in the following ways: - The z-gradient is built into the main magnetic field and, as a result, the system does not require an electromagnetic z-gradient coil - The device includes a template holder to be used for procedures under MR guidance - The device includes an MR guidance user interface workflow such as template calibration and registration with imported MR images