(120 days)
The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data. The Communify PACS Viewer is a software application that runs on standard "offthe-shelf" personal computers, business computers, and servers running . standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulations, create graphical representations of anatomical areas, and perform quantitative measurements.
Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
The Communify PACS Viewer is an application which allows users to view, manipulate, annotate, transmit to other facilities, print, and animate all manner of DICOM images and modalities. These modalities include, but are not limited to, CR, CT, DX, MR, NM, PT, RF, US, and XA.
The Communify PACS Viewer contains common image manipulation functions (such as zoom, pan, triangulation, and window/level) and common image labeling tools (including measurements tools, drawing tools, and annotation overlays). The annotation overlay displays all the important metadata (as configured by the user) for each displayed series study. Although annotation fields depend on the modality and the patient study, the Annotation Overlay Template Wizard provides a full list of annotation fields that the user can assign into the image display.
For easy access to tools and features, there are shortcut keys, toolbars, and right-click menus.
The Hanging Protocol editor of the Communify PACS Viewer configures the presentation layout of images on the screen when a study is loaded. This allows commonly used display formats and presets to be saved and easily accessed to allow for faster case study reviews.
The provided text is a 510(k) summary for the Communify PACS Viewer. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving the device meets those criteria.
Therefore, the requested information, specifically acceptance criteria, device performance metrics, study details, and ground truth establishment, cannot be extracted from the provided text.
The document states:
- "The Communify PACS Viewer meets its intended use and design specifications for a picture archiving and communications system viewer. It has the required capabilities relating to the transfer, display, and digital processing of medical images."
- "It is our conclusion that Communify PACS Viewer is significantly comparable to the PACS Viewers within Opal-RAD, RamSoft PACS, and Centricity PACS Plus."
These statements indicate that the submission relies on the established performance of predicate devices and the functional equivalence of the Communify PACS Viewer to those predicates to demonstrate safety and effectiveness. It does not include a separate study with defined acceptance criteria and performance metrics for the Communify PACS Viewer itself.
§ 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).