(71 days)
The RSVS is intended for use as an image display and keyboard cutry node on a DICOM 3.0 network. It's principal anticipated functions are to merge bitmap images from image sources with keyboard input patient information to form DICOM 3.0 patient image files and provide quality assurance review of such files.
The RIS Scan View System (RSVS) is a DICOM 3.0 compliant secondary capture image application. It can receive, store, transmit, and display images. It provides storage and query/remeval service using C-STORE Service. The RSVS issues a DICOM 3.0 association request, RSVS starts sending the image data to the storage service provider. In addition, it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files. The RSVS is a Microsoft Window based application.
The provided text is a "Summary of Safety and Effectiveness" for the Radiology Information Systems, Inc. RIS Scan View System (RSVS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, the results of a study demonstrating performance, sample sizes, expert qualifications, or ground truth establishment.
The document states:
- Intended Use: The RSVS is intended for use as an image display and keyboard entry node on a DICOM 3.0 network. Its principal anticipated functions are to merge bitmap images from image sources with keyboard input patient information to form DICOM 3.0 patient image files and provide quality assurance review of such files.
- Substantial Equivalence: The RSVS is claimed to be substantially equivalent to the WinRad Teleradiology System (K936179). The comparison table highlights functional similarities like input (Bitmap image), output (DICOM 3.0), store/forward capabilities, and display functions. The only difference noted is that RSVS does not have compression, while WinRad does.
Based on the provided text, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets the acceptance criteria. The document focuses on regulatory approval through substantial equivalence rather than performance validation studies that would include such details.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.