(84 days)
No
The document describes a standard PACS system for managing and displaying medical images. There is no mention of AI, ML, or any related concepts like image processing that would typically indicate the use of such technologies for analysis or interpretation.
No
The device is described as an image management and display system for x-ray and other radiological images. It does not perform any direct therapeutic action or provide treatment. Its function is limited to managing and displaying medical information.
No
The Web Clinical System is intended for managing and displaying x-ray images and other radiological objects and information. It is described as a system for retrieving and browsing medical images, acting as a PACS solution component. This functionality does not involve making medical diagnoses or providing diagnostic information.
Yes
The device description explicitly states it is a "system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks," which aligns with a software-only function for image management and display. There is no mention of 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:
- Intended Use: The intended use clearly states the system is for the "management and displaying of x-ray images, other radiological objects, and information." This involves handling and presenting medical images, not analyzing biological samples or performing tests on specimens taken from the human body.
- Device Description: The description reinforces that the system is for "managing radiological images and data by retrieving and browsing medical images." Again, this focuses on image handling and viewing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This system's function is centered around managing and displaying medical images acquired in vivo (within the body).
N/A
Intended Use / Indications for Use
The Web Clinical System is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.
Product codes
90 LMB
Device Description
The Web-Clinical System (WCS) is a component of the RAYPAX System, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The WCS is a system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray images, other radiological objects, and information. It can manage images from different modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows a logo or wordmark that appears to be for a company or brand named "REMIX". The logo is rendered in a style that gives it a textured or speckled appearance, possibly to create a distressed or vintage effect. The letter "R" is more prominent and solid compared to the rest of the word, which seems to fade or become more sparse as it moves to the right.
510(k) Summary of Safety and Effectiveness OCT 1 3 1999
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
July 16, 1999
Submitter's Information: 21 CFR 807.92(a){1)
SAMSUNG SDS CO., LTD 707-19, Yoksam-Dong, Kangnam-Gu, Seoul, South Korea, 135-080
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Samsung RAYPAX™ Web Clinical System |
|---|---|
| Common Name: | Digital Imaging Workstation |
| Classification Name: | System, Digital Image Communication Accessory |
| Device Classification: | 21 CFR 892.2010 |
Predicate Device: 21 CFR 807. 92(a)(3)
The Samsung SDS Co. Ltd. RAYPAX™ WCS is substantially equivalent to the: Manufacturer: SECTRA IMTEC AB Device Name: Wise II Image Management System 510(k) Number: K983447 9/30/98 Date Received: Decision Date: 10/29/98 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology Panel Code device classified by: Radiology Product Code: 90 LMB Classification: Class I
Device Description: 21 CFR 807 92(a)(4)
The Web-Clinical System (WCS) is a component of the RAYPAX System, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The WCS is a system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks.
Indications for Use: 21 CFR 807 92(a)(5)
The Web Clinical System is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.
1
Image /page/1/Picture/0 description: The image shows a stylized text that appears to read "RIVAGE". The text is rendered in a speckled or grainy texture, giving it a distressed or vintage look. The letter "R" is the most prominent and solid, while the remaining letters gradually fade out, creating a sense of depth or movement.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the WCS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
- The RAYPAX™ WCS system has been designed and will be manufactured in accordance 1. with the voluntary standards listed in the enclosed voluntary standard survey.
-
- The submission contains the results of a hazard analysis and all potential hazards have been classified as Minor.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal bars above a wavy line, representing the department's mission related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Carl Alletto Samsung SDS Co. Ltd. C/O Otech, Inc. 2001 East Oakshores Drive Aubrey, Texas 76227
Re:
RAYPAX™ Web Clinical System (WCS) Dated: July 16, 1999 Received: July 21, 1999 Regulatory class: I 21 CFR 892.2020/Procode: 90 LMD
Dear Mr. Alletto:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in . regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notfication"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "RAX" in a stylized font. The letter "R" is large and bold, while the letters "A" and "X" are smaller and more faded. The letters appear to be made up of small dots, giving them a textured look.
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(Indications for Use Form)
510(k) Number: K992426
Device Name:
Samsung SDS Co. Ltd. RAYPAX™ Web Clinical System
Indications for Use:
- The Web Clinical System is intended for the management and displaying of xray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David G. Hanson
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992426
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)