MR Elastography System

Primary DI

00850011790151

Basic UDI-DI Code

B-00850011790151

Reference

RESYS4001-RESYSAB

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Resoundant

The Resoundant MR Elastography System includes an Active Driver, connective tubing and a Passive Driver. The system generates transverse acoustic waves in the low-audio frequency range in soft tissue during an MRI procedure. 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 Drivers are lightweight enclosures containing no electrical components. They feature a connection for flexible tubing and a diaphragm that is placed securely over patient clothing. The Passive Driver diaphragm is available in both rigid and flexible options for patient comfort. The Resoundant MR Elastography System is intended for use with magnetic resonance diagnostic devices (MRDD). It is indicated for generating acoustic vibrations in soft tissue during MRI procedures, 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.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).