Search Results

M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.

M-Vu Breast Density automatically analyzes "for processing" digital mammograms and calculates the dense tissue area of each breast. The measured dense tissue area is then used to provide a Calibrated Density Category which maps the percentage of breast density to a BI-RADS category number (1 - 4). M-Vu Breast Density is a stand-alone software application designed to interoperate with all digital radiography (DR) and computed radiography (CR) mammography systems. M-Vu Breast Density is displayed in the form of a DICOM mammography structured report or secondary capture and reports the following for output: - Breast Area (cm2) for cach breast . - Dense Area (cm2) for each breast . - Percent Breast Density for each breast . - . Breast Density Category for each case The results of M-Vu Breast Density are designed to display on a mammography workstation, high resolution monitor. or in a printed case report. M-Vu Breast Density is designed to process approximately 60-120 cases per hour. M-Vu Breast Density Version 1.0.0.0 has been built and tested on the M-Vu CAD Station system (K061160).

The M-Vu™ CAD Station is intended to support the acquisition and storage of medical images for subsequent digital analysis and processing. The medical imagery can be obtained from film format (digitized by a commercial FDA-cleared medical digitizer) or digital format transmitted via a standard DICOM network interface. The CAD Station can print case information and can connect over a Local Area Network and interface with the M-Vu Viewer Station. The CAD Station is intended for use by a technician under the supervision of a medical professional. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

The M-Vu™ CAD Station is a computer-based system that supports the acquisition and storage of medical images for subsequent digital analysis and processing. The system can obtain digitized imagery from two sources: 1) digitized film images from a medical digitizer that is included as part of the system or 2) digitized images obtained from different sources and sent to the CAD Station via a DICOM network interface. The CAD Station is not intended as an archival device. The CAD Station has several commercial components integrated together on a custom cart. The components include a 510(k)-cleared medical digitizer for scanning films, a printer for report generation, a touch screen monitor for control and displaying system status and error messages, a Windows™-OS computer for executing control software and for temporary storage of imagery and an uninterruptible power supply. The CAD Station communicates via a standard Ethernet network and can support an interface to other PACS devices through a DICOM interface. It also communicates to the M-Vu™ Viewer Station (K060451) to provide case reports including low resolution radiographic images. The user interface to the CAD Station is via a touch screen monitor. The monitor allows control of the digitizer and provides system status information. While the system is intended to be operated in an unattended batch mode, case priorities can be manually adjusted for higher priority film or digital cases. Also, user specific configuration information and options can be accessed through an onscreen keyboard. The printer automatically generates case reports with low resolution imagery and a printed (unique) bar code. The bar code is then used to link the case reports to the graphical imagery on the M-Vu Viewer Station.

The M-Vu™ Viewer Station is intended to be used to display low resolution, non-diagnostic, medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.

The M-Vu™ Viewer Station is a computer-based system that displays digitized. low-resolution, radiographic information. The system is typically used to support a radiologist's review of screening and/or diagnostic mammograms. The system has two main functional components: a commercially available computer with an integrated LCD display and an attached bar code reader. The computer is connected to the M-Vu™ CAD Station via an Ethernet network to download selected radiographic images and Computer-Aided Detection (CAD) results or other annotations. The Viewer Station serves no other purpose than providing convenient viewer support.