MyoStrain

Primary DI
B672MYOSTRAIN060100
Brand
MyoStrain
Company
MYOCARDIAL SOLUTIONS, INC.
Model
6.1
Device description
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 of complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by a physician and can be communicated to referring physicians to support the determination of a diagnosis.
Published
2025-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B672MYOSTRAIN060100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080294654
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B673MYOSTRAIN05040MyoStrain5.42021-09-22
B673MYOSTRAIN0502030MyoStrain5.2.32021-04-16
B673MYOSTRAIN0502020Myostrain5.2.22020-10-10
B672MYOSTRAIN0600010MyoStrain6.0.12024-11-12
B672MYOSTRAIN050102MyoStrain5.1.22019-03-05

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