Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and Switzerland.
Description du dispositif
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. || The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.