(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.
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Image /page/0/Picture/0 description: The image is a black and white abstract pattern. The pattern is made up of small, irregular shapes that are arranged in a seemingly random order. The shapes are mostly black, but there are also some white shapes scattered throughout the pattern. The overall effect is one of chaos and disorder.
RADIOLOGY INFORMATION SYSTEMS
MAY - 2 1997 K970641
Appendix 5, Summary of Safety and Effectiveness Radiology Information Systems, Inc. RIS Scan View System (RSVS)
- 1.0 Submitted Joe Pi President Radiology Information Systems, Inc. 2004 Adams Hill Road Vienna, VA. 22182 (703) 255-2774 (P) (703) 255-5519 (F)
Technical Contact Chen-Tai Ma VP Bagineering (SAME)
This summary was prepared on: February 17, 1997
- 2.0 Product
| Trade Name: | Radiology Information Systems, Inc. RIS Scan View System (RSVS) |
|---|---|
| Common Name: | DICOM 3.0 compatible medical image display station |
| Classification Name: | Picture Archiving and Communication System (PACS). |
Proposed 892.2050 classifies PACS in Class II.
- 3.0 Predicate Device
The RSVS is substantially equivalent to the WinRad Teleradiology System (K936179) manufactured by Line Imaging Systems.
4.0 RIS ScanView System
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.
5.0 RIS Scan View System Intended Use
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
2005 A tripps Bill 850 -Victor VA . 2181 2017 783 75 1132 back (2011) 11:54 : 10
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Image /page/1/Picture/0 description: The image shows a black and white drawing of what appears to be a city map or aerial view of a densely populated area. The drawing is characterized by numerous small, dark shapes that likely represent buildings or structures. These shapes are clustered together, forming patterns that suggest streets and blocks within the urban landscape. The overall impression is that of a complex and intricate urban environment, possibly a section of a large city.
RADIOLO GY INFORMATION SYSTEMS
information to form DICOM 3.0 patient image files and provide quality assurance review of such files.
- 6.0 Statement of Substantial Equivalence The RSVS is substantially equivalent to the WinRad Teleradiology System (K936179) manufactured by Line Imaging Systems. The significant features of each device are compared below.
| Function | RIS RSVS | WinRad |
|---|---|---|
| Input | Bitmap image | Bitmap image |
| Output | DICOM 3.0 | DICOM 3.0 |
| Store/Forward | yes | yes |
| Display Functions | yes | yes |
| Compression | no | yes |
2004 Algar Hill Road Victor, VA 20182 Tel: (703) 757 0030 Fax: (70) 255-3519
TOTAL P. 06
§ 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.