MyoStrain

Primary DI

+B672MYOSTRAIN502040/$$05320204/*

Basic UDI-DI Code

++B672MYOSTRAIN2Q

Reference

5.2.4

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Myocardial Solutions, Inc.

MyoStrain software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing.  Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart.  Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats.  This interface makes it possible to quickly and reliably fill out a complete clinical report of a cardiac imaging exam with strain.  The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.

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