Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K241607
    Device Name
    MyoStrain (6.0)
    Manufacturer
    Myocardial Solutions, Inc.
    Date Cleared
    2024-08-26

    (83 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Myocardial Solutions, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected and presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.
    Ask a Question
    K Number
    K182756
    Device Name
    MyoStrain 5.1
    Manufacturer
    Myocardial Solutions
    Date Cleared
    2019-02-14

    (139 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Myocardial Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 the physician and can be communicated to referring physicians to support the determination of a diagnosis.
    Device Description
    The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view and analyze SENC MR images of the heart in DICOM format. MyoStrain quantifies regional and global cardiac function from SENC images by implementing the SENC processing methods. With a friendly graphic user interface, users are able to analyze SENC MR images and obtain fast and reproducible measurements of myocardial strain, ejection fraction, and volumes. Measurements are collected presented on screen as a report showing values as colors and numbers, and this report can be printed or exported in digital format.
    Ask a Question

    Page 1 of 1