Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K161959
    Device Name
    ClearView cCAD
    Manufacturer
    ClearView Diagnostics Inc.
    Date Cleared
    2016-12-28

    (163 days)

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

    ClearView Diagnostics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs). The software allows the user to annotate, and automatically record and/or store selected views. The software also automatically generates reports from user inputs annotated during the image analysis process as well as the automatically generated characteristics. The output of this system will be a DICOM compatible (e.g. grayscale softcopy presentation state (GSPS)) and/or PDF report that can be sent along with the original image to standard film or paper printers or sent electronically to an intranet webserver or other DICOM compatible device. cCAD includes options to annotate and describe the image 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 decision should not be made solely on the results of the cCAD analysis. The ultrasound images displayed on cCAD must not be used for primary diagnostic interpretation.
    Device Description
    ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs). The device uses multivariate pattern recognition methods to perform characterization and classification of images. For breast ultrasound, these pattern recognition and classification methods are used by a radiologist to analyze such features as shape, orientation, and putative BI-RADS® category which can then be used to describe the lesion in the ACR BI-RADS® breast ultrasound lexicon as well as assigning an ACR BI-RADS® categorization which is intended to support compliance with the ACR BI-RADS® ultrasound lexicon classification form. Similarly, this process can be used to assist in training, evaluation, and tracking of physician performance. The cCAD software can be run on any Windows 7 or higher or Windows Embedded platform that has network, Microsoft IIS, and Microsoft SQL support and is cleared for use in medical imaging. The software does not require any specialized hardware, but the time to process ROIs will vary depending on the hardware specifications. ClearView cCAD is based on core BI-RADS models and lesion characteristic extraction algorithms that can use novel statistical, texture, shape, orientation descriptors, and physician input to help with proper ACR BI-RADS® assessment. The ClearView cCAD processing software is a platform agnostic web service that queries and accepts DICOM compliant digital medical files from an ultrasound device, another DICOM source, or PACS server. To initiate analysis and processing, images are queried from a compatible location and loaded for display within the application. The user then selects an ROI to analyze by clicking and dragging a bounding box around the region requiring analysis. Once selected, the user then clicks the processing button which initiates the analysis and processing sequence. The results are displayed to the user on the monitor and can then be selected for automated reporting, storage, or modification. The output of this system will be a DICOM compatible overlay (e.g. grayscale softcopy presentation state (GSPS)) and/or PDF report that can be sent along with the original image to standard film or paper printers or sent electronically to an intranet webserver or other DICOM compatible devices distributed by various OEM vendors. All fields may be modified by the user at any time during the analysis and prior to archiving.
    Ask a Question
    K Number
    K140139
    Device Name
    CLEARVIEWHD
    Manufacturer
    CLEARVIEW DIAGNOSTICS INC.
    Date Cleared
    2014-05-28

    (126 days)

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

    CLEARVIEW DIAGNOSTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast, and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image interpretation by the trained physician.
    Device Description
    The ClearViewHD image processing software reduces noise and enhances contrast of medical ultrasound images. The software is a Windows XP or higher, Windows Embedded, and DICOM-compatible platform that may be installed on a standalone PC, laptop, or tablet The software does not require any specialized hardware but the time to process an image will vary depending on the hardware specifications. ClearViewHD is based on a core noise reduction and contrast enhancement algorithm that uses novel statistical techniques to determine whether each pixel location is due to mostly noise or signal (tissue structure) and attenuates the regions due to noise while preserving and accentuating the regions due to tissue structure. The statistical method is based on the a priori knowledge that the ultrasound signal is sparse and compressive sampling theory can be used to reconstruct the signal with fewer samples than the Nyquist Rate specifies. The Clear ViewHD image processing software is a DICOM node that accepts DICOM3.0 digital medical files from an ultrasound device or another DICOM source. ClearViewHD processes the image and returns the original and/or enhanced image to another DICOM node such as a specific PC/workstation or the PACS system. The ClearViewHD software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors.
    Ask a Question

    Page 1 of 1