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The Motion Correction System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system is a sensorbased technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner for further data processing. User: Professional Use Environment: Hospital, doctor's office, or any facility that uses an MRI device KinetiCor defines the Motion Correction System as an accessory to a medical device. It is intended to supplement and/or augment the performance of the MAGNETOM Skyra 3T MRI scanner.

During an MRI scan, if the patient's head does not remain still during the scan, the resulting images may not be sharp. This could prevent a physician from analyzing the images, therefore requiring additional scanning. Software has been developed to somewhat reduce these effects. KinetiCor has developed a Motion Correction technology using a track the true position of the patient's head. These coordinates are provided to the MRI scanner, which adjusts the MR images. The Motion Correction System delivers head pose tracking and correction in 6 degrees of freedom for MR applications. - . Optimized for high field MR environments, the technology has been FDA Cleared for use in the MAGNETOM Vida, 510(k) K183254, cleared January 18, 2019. Customized optics, electronics and enclosures minimize Electromagnetic Interference (EMI) and Radiofrequency (RF) interference and isolate the camera system for stable tracking accuracy. - . Proprietary optical machine vision tracking technology provides tracking data to the MRI scanner with a static accuracy of approximately 0.1 mm and 0.1 deg. This means that the MR pulse sequences are updated in real-time. - The impact of the Motion Correction technology can be illustrated by taking a closer look at the corrected and uncorrected images in the figure below. The Motion Correction System Hardware consists of the following: - Camera Enclosure (incorporating four Cameras) located inside the distal end of the MRI scanner; ● - Wiring Conduit - provides a protected location for wiring to exit the distal end of the MRI scanner; - Processing Unit - electronics with software, located outside the MRI room; - External Wiring - used to connect processing unit to Camera Enclosure; - . Tracking Markers - single use markers located on patient nose bridge (Referred to as "Nose Marker for Inline Motion Correction" in predicate device); - External Monitor - if requested, located inside MRI Control Room; - Network System located outside the MRI room.