MyoStrain - MyoStrain software is an image processing device - MYOCARDIAL SOLUTIONS, INC.

Duns Number:080294654

Device Description: MyoStrain software is an image processing device that post-processes strain-encoded (SENC) 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.

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More Product Details

Catalog Number

-

Brand Name

MyoStrain

Version/Model Number

5.2.3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 01, 2031

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182756

Product Code Details

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Device Record Status

Public Device Record Key

c7e0ba1c-7efa-4ece-9fc6-bfc2f6482149

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MYOCARDIAL SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4