InVision™ 3T Recharge Operating Suite

The InVision™ 3T Recharge Operating Suite is an intraoperative MRI system featuring a Siemens MAGNETOM Skyra Fit 3T scanner suspended on an overhead rail. It produces cross-sectional MR images of the head, body, and extremities for diagnostic purposes and can be moved between an operating room and diagnostic room during surgical procedures, allowing real-time imaging without moving the patient.

The primary difference from the predicate device (IMRIS iMRI 3T V) is substitution of the Siemens MAGNETOM Skyra Fit scanner for the MAGNETOM Vida scanner. Both are 3 Tesla, actively shielded superconducting magnets. The accessory components (intraoperative imaging coils, operating room table, head fixation device, rail system, magnet mover) remain substantially equivalent. Software and application platform were updated (IMRISmatrix 5 replacing VISIUSmatrix 4), and magnet mover components were modified to accommodate the different scanner.

ANSI/AAMI ES60601-1:2005 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility; NEMA MS 4, MS 6, and MS 9 for MRI-specific performance; IEC 62304 for software lifecycle; ISO 14971 for risk management; ISO 10993 for biocompatibility. Clinical images were assessed per FDA guidance on Premarket Notifications for Magnetic Resonance Diagnostic Devices.

Both devices share identical intended use (diagnostic MRI in intraoperative and multi-room settings), same regulatory classification (Class II, product code LNH/LNI/MOS), and equivalent indications for use. Although the scanner model differs, both are 3T actively shielded magnets with comparable imaging capabilities. Verification and validation testing of the Skyra Fit integration, including functional testing, imaging performance testing, and sample clinical images, demonstrated that the proposed device maintains clinically acceptable MR imaging performance equivalent to the predicate. The technological differences (different scanner model, updated software, modified magnet mover) do not raise new safety or effectiveness questions because the underlying MRI physics and intraoperative operating principles remain the same.