I-Genius (100019400)
Esaote, S.p.A.The I-Genius is an intraoperative MRI device used to scan the skull and brain. It helps surgeons and clinicians visualize brain structures in real time during procedures, potentially improving surgical outcomes and patient safety.
Intended Use
The I-Genius device is intended for intraoperative use in a shielded operating room to image portions of the head, specifically the skull and brain.
Technology
I-Genius uses the same base MRI technology and the same magnet unit as its predicate device, with improved operator interface, touch screen controls, and overall workflow. It is designed for intraoperative use and offers enhanced operation for real-time imaging.
Performance
Nonclinical and software validation testing was conducted. Clinical testing involved a board-certified radiologist who reviewed images obtained from the device for sufficient quality for diagnostic use.
Predicate Devices
No predicate devices specified
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