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IMRIS, Deerfield Imaging Wins FDA 510(k) Clearance for New iMRI 3T-V Surgical System

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Global leader in intraoperative imaging, IMRIS, Deerfield Imaging, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the new iMRI 3T-V Surgical System, a multifunctional surgical environment designed to deliver unmatched intraoperative vision for clinicians, assist in surgical decision-making and enhance precision in treatment.

This newest imaging technology, based on Siemens MAGNETOM Vida, provides improved imaging speed, image quality and efficiency of scan acquisition by minimizing motion artifacts and sedation/anesthesia times thus decreasing the time to results. The new system utilizes Siemens BioMatrix 3T Technology that adapts to patient differences, reducing exam variations and rescans while enhancing results.

The IMRIS iMRI 3T-V Surgical Theatre, which was FDA cleared with our patented magnet mover technology, is available in a two-room or three-room configuration and features a 3 Tesla high-field MR scanner that will travel into the operating room on demand. This will provide intraoperative images of diagnostic quality without moving the patient and thereby minimizing associated risks. Clinicians will have access to real-time information while optimal surgical access and techniques are preserved. With integrated tools and technology designed specifically for neurosurgical applications, the IMRIS Surgical Theatre will allow optimal patient positioning for use of intraoperative MRI. Once positioned, it is unlikely the patient will ever need to be moved for scanning – before, during or after a procedure. Our patented ceiling-mounted rail system, the IMRIS Magnet Mover, is truly a one-of-a-kind innovation.

Source: IMRIS, Deerfield Imaging.

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