(50 days)
BeyondImage Workstation is a software application that is used for viewing medical images. Beyond mage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Taking that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images, it also provides standard Multi-Planar Reconstruction (MPR) views, Curved-Planar Reconstruction (CPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using Beyondlmage Workstation, users can edit and print report.
Beyondlmage Workstation cannot display and process mammograms.
Typical users of Beyondlmage Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
BeyondImage Workstation is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM format. Beyondlmage Workstation can also transfer images in DICOM 3.0 format over a medical imaging network, as well as exporting images to applications in other proprietary formats.
The provided text is a 510(k) Summary of Safety and Effectiveness for the BeyondImage Workstation 2.0. This document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's functionality. It does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or information on sample sizes, ground truth establishment, or expert involvement for a performance study.
Therefore, I cannot extract the requested information from the provided text. The document acts as a regulatory submission confirming the device's intended use and technological similarity to existing approved devices, rather than a detailed report of a performance study with specific metrics and methodologies.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).