Search Results

The vRad Viewer software is used with general purpose computing hardware which meets or exceeds minimum specifications. The vRad Viewer is intended to receive, display, and transmit images for clinical purposes. The vRad Viewer is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with storage components. The vRad Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad Viewer can process medical images from DICOM modalities, such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. The vRad Viewer may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and may only be used on monitors determined to be appropriate for the desired task.

The vRad Viewer is a Software as a Medical Device (SaMD) that imports medical data in the Digital Imaging and Communications and Medicine (DICOM) standard from local storage or remote Picture Archiving and Communications System (PACS) sources. The vRad Viewer is a modified version of the Viewer component cleared as part of vRad PACS with Mammography (K162145). Like the Viewer component of the vRad PACS with Mammography device, the vRad Viewer is intended to allow users to visualize, manipulate, and interpret medical images from X-ray radiography, X-ray computed tomography, MRI, ultrasound, nuclear medicine, and other DICOM-compliant modalities on compatible PC workstations. The vRad Viewer is designed to interface with radiologist workflow applications, such as PACS or caching applications, as well as operate as a standalone image viewer. The vRad Viewer allows users to perform operations related to the manipulation, enhancement, compression, and quantification of medical images at the command of the operator and based on user preferences. Other workflow tools (e.g., Color Map, Window Level Presets, Overlay Display Schemes) exist within the Viewer to allow for operator customization of display and usage preferences. The Viewer is a Microsoft Windows-based software application that runs on "off-the-shelf" computers that meet the specified minimum basic computer configuration for the Viewer and are running Microsoft Windows 10 Operating System (OS). For operator input and control of the software, standard Microsoft Windows-compatible input devices are used, including keyboards of various configurations, multi-button mice, grips, foot pedal controls, the Contour ShuttlePRO (Jog-Dial), etc. The vRad Viewer is not a hardware device; however, a monitor is required to display images and to interface with the software. Image quality may vary depending on the display monitor, and users must utilize a compatible monitor that meets technical specifications required for the tasks intended to be performed by the user.

The vRad PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with vRad PACS Storage component. The vRad PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. The vRad Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer. vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA.

vRad PACS with Mammography is a device which consists solely of software that allows electronic transmission of radiological patient images from one location to another. The device is capable of accepting, storing, digitally processing, and displaying medical images for the purposes of providing digital diagnostic image interpretation services by trained radiologists on PC workstations. The software provides functions for performing operations related to manipulation, enhancement, compression, and quantification of medical images. vRad PACS with Mammography is a modified version of vRad PACS (K090649) that will now allow display of presentation-quality digital mammography images.

The vRad™ PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRad™ PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad™ PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad™ PACS Storage component. The vRad™ PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad™ PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities. The vRad™ PACS system should not be used for Mammography primary image diagnosis.

vRad™ PACS is a device which consists solely of software and allows electronic transmission of radiological patient images from one location to another. The device has the capability to accept, transfer, display, store, and digitally process medical images to trained and qualified radiologists for the purposes of providing digital diaging The software provides functions for performing operations interpretation services. related to image manipulation, enhancement, compression, and quantification of medical images (except mammography images). The software enables the user to display 3D maximum intensity projection (MIP) and Multi-Planar Reformatting (MPR) visualization of study images.