Device Dossier
Magnetic resonance elastography acoustic driver
Device Dossier for Magnetic resonance elastography acoustic driver (Magnetic resonance elastography acoustic driver, Class IIa, sponsor Philips…
- GMDN category: Magnetic resonance elastography acoustic driver
Intended purpose
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