RIS SCANVIEW SYSTEM (RSVS)

K970641 · Radiology Information Systems, Inc. · LMD · May 2, 1997 · Radiology

Device Facts

• Record ID: K970641
• Device Name: RIS SCANVIEW SYSTEM (RSVS)
• Applicant: Radiology Information Systems, Inc.
• Product Code: LMD · Radiology
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The RSVS is intended for use as an image display and keyboard entry 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.

Device Story

RSVS functions as DICOM 3.0-compliant secondary capture image application; operates as image display and keyboard entry node on network. Inputs: bitmap images from imaging devices and manual keyboard data entry. Processing: merges bitmap images with patient information to create DICOM 3.0 image files; provides storage, query, and retrieval services via C-STORE. Output: DICOM 3.0 patient image files for quality assurance review. Used in clinical settings by radiology staff to manage and verify image data integrity before archival or transmission.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

DICOM 3.0 compatible image display station; Microsoft Windows-based application; network-connected node; supports C-STORE service; secondary capture functionality.

Indications for Use

Indicated for use by healthcare professionals as a DICOM 3.0 network node for image display, keyboard entry of patient data, merging of bitmap images with patient information, and quality assurance review of DICOM 3.0 patient image files.

Regulatory Classification

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.

Predicate Devices

• WinRad Teleradiology System (K936179)

Submission Summary (Full Text)

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RADIOLOGY INFORMATION SYSTEMS

MAY - 2 1997

K970641

Appendix 5, Summary of Safety and Effectiveness Radiology Information Systems, Inc. RIS ScanView System (RSVS)

1.0 Submitted
Joe Pi
President
Radiology Information Systems, Inc.
2004 Adams Hill Road
Vienna, VA. 22182
[phone] (F)
[phone] (F)

Technical Contact
Chen-Tai Ma
VP Engineering
(SAME)

This summary was prepared on: February 17, 1997

2.0 Product
Trade Name: Radiology Information Systems, Inc. RIS ScanView 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 ScanView 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/retrieval 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 ScanView System Intended Use
The RSVS is intended for use as an image display and keyboard entry node on a DICOM 3.0 network. It's principal anticipated functions are to merge bitmap images from image sources with keyboard input patient

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RADIOLOGY 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 |

2001 Adams Hill Road
Vienna, VA 22182
Tel: [phone]
Fax: [phone]

TOTAL P.06