MR Elastography; MZEK-OO1A Overview
The MR Elastography; MZEK-OO1A is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.
Indications for Use
The device is intended for prescription use and is classified as a Magnetic Resonance Diagnostic Device (MRDD) under 21 CFR 892.1000.
Device Classification and Product Code
The device is classified as Class II and has a product code of 90-LNH.
Predicate Devices
The predicate devices for this submission are MR Elastography (K140666) and MR Elastography, Resoundant (K201389).
Manual:
Download: MR Elastography; MZEK-OO1A User Manual
Chat: Powered By VoiceSphere