Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K103761
    Device Name
    VISUALIZE: VASCULAR
    Manufacturer
    THE MEDIPATTERN CORPORATION
    Date Cleared
    2011-02-11

    (50 days)

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

    THE MEDIPATTERN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visualize: Vascular is a software application package. It is designed to view and quantify image data acquired on commercially available ultrasound products. Regions of interest can be segmented, measured and annotated. The results can be displayed in 2D or 3D. The system automatically generates reports of user inputs.
    Device Description
    Visualize: Vascular™ 1.0 is a software application designed to assist in visualization, analysis and reporting of ultrasound vascular images. All images acquired for use with Visualize must be obtained using the data acquisition protocol found in the Visualize: Vascular User Guide. Visualize: Vascular displays cine clips in stack mode, which can be viewed going forward and in reverse. When the user selects a region(s) of interest within the cine clips, Visualize provides a 3D volume reconstruction and surface rendering of the segmented information. The user can manipulate and annotate the 3D reconstructed images. Visualize can also map the cine colour flow information provided by the ultrasound system onto the 3D rendered data. Visualize provides an automated method to measure the narrowest and widest sections of segmented areas. Visualize: Vascular displays 2D sagittal ultrasound images and provides a manual tool for measurements to be recorded on these 2D images. The software application automatically generates reports from user inputs annotated during the image analysis process. The user may select the images, measurements and clinical findings to display in the report. All fields may be modified by the user at any time during the analysis and prior to archiving. An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device. The Visualize software is a Windows 7, DICOM-compatible platform that may be installed on a standalone PC, PACS, imaging system or embedded in software applications cleared for use in medical imaging. The Medipattern software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM ultrasound equipment manufacturers. Visualize: Vascular is a software application package. It is designed to view and quantify image data acquired on commercially available ultrasound products. Regions of interest can be segmented, measured and annotated. The results can be displayed in 2D or 3D. The system automatically generates reports of user inputs.
    Ask a Question
    K Number
    K050846
    Device Name
    B-CAD SYSTEM, VERSION 1.0
    Manufacturer
    THE MEDIPATTERN CORPORATION
    Date Cleared
    2005-05-26

    (52 days)

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

    THE MEDIPATTERN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    B-CAD is a computer-aided detection (CAD) software application designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI). The software allows the user to annotate, tag, measure, and automatically record selected views. The software automatically generates reports from user inputs annotated during the image analysis process. An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device. B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to support compliance with the ACR-BI-RADS® Ultrasound Lexicon Classification Form. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made solely on the results of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation.
    Device Description
    B-CAD is a computer-aided detection (CAD) software application, designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI). The device uses multivariate pattern recognition methods to perform tissue segmentation and classification of images. For breast ultrasound, these pattern recognition methods are used by a radiologist to analyze such features as shape and orientation [refer to American College of Radiology's (ACR) Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas and ACR-BI-RADS® Ultrasound lexicon]. The software application consists of proprietary software developed by The Medipattern Corporation. The software is a Windows 2000/XP, DICOMcompatible platform that may be installed on a standalone PC, PACS, or embedded in software applications cleared for use in medical imaging. The B-CAD user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images. The Medipattern software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors. To initiate B-CAD analysis and processing, images are acquired and pushed to the software application from an ultrasound imager for review and further analysis on a monitor. The user selects a ROI by clicking on a seed point and dragging the cursor to the selected boundary of the ROI. A circle appears, defining the region of interest. Once the ROI is selected, the B-CAD software initially displays a gallery of up to six segmented views on the monitor. The user may select any view for further analysis of anatomy and pathology. The software allows the user to annotate, tag, measure, and automatically record selected views. Results of the analysis are displayed on the monitor and may be selected by the user for automated reporting. The software application automatically generates reports from user inputs annotated during the image analysis process. The user may select inputs for the report from various pull-down menus and toggle buttons and the user may direct the B-CAD software to prepopulate various fields contained in the report. All fields may be modified by the user at any time during the analysis and prior to archiving.
    Ask a Question

    Page 1 of 1