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The Resoundant Acoustic Driver System is intended for use with magnetic resonance diagnostic devices (MRDD) that include legally marketed MR elastography capabilities. It is indicated for generating acoustic vibrations in the body during an MRI exam, in order to assess tissue elasticity for diagnostic purposes as part of magnetic resonance elastography (MRE). When interpreted by a trained physician, this information can be useful in determining a diagnosis.

The Resoundant Acoustic Driver System includes an Active Driver, connective tubing and a Passive Driver. The system generates transverse acoustic waves in the low-audio frequency range in the body during an MRI exam. This allows assessment of elastic properties of soft tissue to aid in medical diagnosis as part of magnetic resonance elastography (MRE). The Active Driver component is an electro-mechanical device that consists of a function generator, power-amplifier, linear motor and pump head, along with a microprocessor-based controller and power supply electronics, in an enclosure. The Passive Driver component is connected to the Active Driver through flexible tubing and is used to induce small vibrations in the scan subject. The Passive Driver is a lightweight enclosure containing no electrical components. It features a connection for flexible tubing and a diaphragm that is placed securely over patient clothing.

MREplus+ Software is an assisted ROI drawing tool for liver MRE and Fat/Water images and is used for receiving, display, ROI selection, and analysis generation. It displays to a trained reader MRE and Fat/Water images, preliminary ROIs that it calculates from these images, and statistical analysis calculated from the ROIs and images are presented in a way for review and, optionally, modification by the trained reader.

The MREplus+ software is a tool for assisted Magnetic Resonance Elastography (MRE) and multipoint Dixon Fat/Water (FW) image analysis which calculates preliminary automated regions of interest (ROIs) and provides the environment for the trained readers to review the relevant MRE and FW information and approve or modify the ROIs. MREplus+ is intended to be used only with liver MRE and FW data. The inputs for MREplus+ are the MRE and FW images. In the case of MRE, this includes magnitude images (showing anatomy), wave images (showing wave propagation) with multiple time points across the wave cycle, and the elasticity and confidence images calculated by MRE's on-scanner MMDI algorithm or an offline MMDI packaged with MREplus+. In the case of FW, images include in-phase, out-of-phase, fat, water, fat fraction, and R2*. MREplus+ includes a DICOM receiver which can recognize and accept these images when sent from the MRI scanner or workstation using standard protocols. From these images, MREplus+ calculates automated ROIs. ROIs can be reviewed by an authorized trained reader for review, modification and approval. MREplus+ performs statistical calculations from the ROIs. MREplus+ outputs images, ROIs, and calculated results in an archive compatible report.