(71 days)
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No
The summary describes a standard DICOM image display and capture system with basic image merging and storage functions. There is no mention of AI, ML, or any advanced image processing that would typically involve these technologies.
No
The device is described as an image display and keyboard entry node that processes and manages DICOM 3.0 patient image files for quality assurance review. Its functions are related to image handling and information merging, not to directly treating or preventing disease.
No
The device is an image display and keyboard entry node that creates and reviews DICOM 3.0 patient image files. It does not perform any diagnostic analysis of the images.
Yes
The device description explicitly states it is a "Microsoft Window based application" and a "DICOM 3.0 compliant secondary capture image application," focusing on software functions like receiving, storing, transmitting, displaying, and merging images and information. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- The RSVS's intended use and device description clearly state its function is related to image display, keyboard entry, merging bitmap images with patient information, creating DICOM files, and quality assurance review of these files. It deals with medical images, not biological specimens.
The device is a medical imaging software application used within a DICOM network, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for 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 information to form DICOM 3.0 patient image files and provide quality assurance review of such files.
Product codes
892.2050
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Bitmap image
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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