(70 days)
MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a software application for viewing medical images. Typical MedCommons Gateway™ users are healthcare professionals, such as, clinicians, radiologists, and technologists.
MedCommons Gateway™ receives, communicates, and displays digital images and data from various types of imaging and image processing system, such CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources). MedCommons Gateway™ can be integrated with an institution's HIS or RIS, linking or transferring images and data into electronic patient records.
MedCommons Open Radiology™ Gateway (MedCommons Gateway™) is a component of a Picture Archiving and Communications System (PACS). MedCommons Gateway™ 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 and/or other proprietary formats. MedCommons Gateway™ can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in JPEG and/or proprietary formats.
The provided text is a 510(k) summary for the MedCommons Open Radiology™ Gateway. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (eFilm Workstation) based on device description, intended use, and similar features. It is a regulatory submission for market clearance, not a report of a performance study with specific acceptance criteria.
Therefore, I cannot provide the requested table and study details. The document explicitly states:
- Substantial Equivalence: The MedCommons Open Radiology™ Gateway is substantially equivalent to the eFilm Workstation, which was cleared in 510(k)'s K020995 and K012211.
- Comparison to the predicate device: The MedCommons Open Radiology™ Gateway and the eFilm Workstation are both software applications intended for viewing medical images stored in PACS systems. They have similar features and are substantially equivalent in safety and effectiveness.
This indicates that the clearance was based on similarity to an already approved device, rather than a new clinical performance study with defined acceptance criteria and subsequent testing against them for this specific device.
§ 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).