Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K111833
    Device Name
    VIRTUE
    Manufacturer
    DIAGNOSOFT, INC.
    Date Cleared
    2011-09-21

    (85 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.
    Device Description
    The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze MR images of the heart in DICOM format.
    Ask a Question
    K Number
    K100352
    Device Name
    DIAGNOSOFT HARP MODEL 2.06
    Manufacturer
    DIAGNOSOFT, INC.
    Date Cleared
    2010-03-11

    (27 days)

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

    DIAGNOSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnosoft, Inc. HARP 2.06 is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization. Tagged MR images can be imported, displayed and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of 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 an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
    Device Description
    The Diagnosoft, Inc. HARP 2.06 is intended for the quantification of regional and global cardiac function from magnetic resonance images. It includes a user friendly implementation of the HARP methods for fast and reproducible measuring of myocardial motion and strain in the heart. With a friendly graphic user interface, users are able to analyze tagged MR images in minutes and produce many measurements including strain, torsion, and regional wall thickening.
    Ask a Question
    K Number
    K061368
    Device Name
    DIAGNOSOFT HARP
    Manufacturer
    DIAGNOSOFT, INC.
    Date Cleared
    2006-07-28

    (73 days)

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

    DIAGNOSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization. Tagged MR images can be imported, displayed, and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of 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 an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
    Device Description
    DIAGNOSOFT HARP is a stand-alone software package, designed for the Microsoft Windows operating system, providing the capability to import, display, and analyze magnetic resonance images of the heart. HARP imports DICOM images containing anatomical MRI, tagged MRI, perfusion MRI, or delayed enhancement MRI and is independent of the MR scanner manufacturer. HARP is intended to support clinicians in the diagnosis of heart disease.
    Ask a Question

    Page 1 of 1