(75 days)
Not Found
No
The document describes a standard medical image display workstation with image processing functions, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No
The device is a display workstation for medical images, designed for image processing, storage, and communication, not for direct diagnosis or treatment.
No
The device is a display workstation for medical images, allowing storage, communication, processing, and display of images. It does not perform diagnostic interpretations or generate a diagnosis; it presents data for a human to interpret.
No
The description refers to a "Display Workstation," which implies a hardware component (a computer or dedicated workstation) is part of the device, even if the primary function is software-based image processing and display. The summary does not explicitly state it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Samsung RAYPAX™ Display Workstation is described as a device that receives, stores, processes, and displays digital medical images from various imaging modalities (CT, MR, Ultrasound, etc.). It is a component of a PACS (Picture Archiving and Communication System).
- No mention of biological samples: The description focuses entirely on the handling and display of medical images, not on the analysis of biological samples.
Therefore, the device's function aligns with medical imaging and PACS technology, not with in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.
The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.
Product codes
90 LMD, 90 LLZ
Device Description
The Display Workstation is one of the components of the RAYPAX, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The Display Workstation provides image-processing functions and workflow for the radiology department for medical images that are acquired and stored in the RAYPAX image server in DICOM 3.0 format.
Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians, nurses, and medical technicians.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K99 2306
SEP 22 1999
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
June 30, 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™ Display Workstation System |
|---|---|
| Common Name: | Digital Imaging Workstation |
| Classification Name: | System, Digital Image Communication accessory |
| Device Classification: | 21 CFR 892.2020 |
Predicate Device: 21 CFR 807. 92(a)(3)
| Manufacturer: | Olicon Imaging Systems, Inc |
|---|---|
| Device: | 02-Workstation & PACS View Software |
| 510(k) Number: | K973959 |
| Date Received: | 10/16/97 |
| Decision Date: | 12/22/97 |
| Decision: | Substantially Equivalent |
| Panel Code device reviewed by: | Radiology |
| Panel Code device classified by: | Radiology |
| Product Code: | 90 LMD |
| Classification: | Class II |
Device Description: 21 CFR 807 92(a)(4)
The Display Workstation is one of the components of the RAYPAX, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The Display Workstation provides image-processing functions and workflow for the radiology department for medical images that are acquired and stored in the RAYPAX image server in DICOM 3.0 format.
Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.
1
Indications for Use: 21 CFR 807 92(a)(5)
The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.
The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.
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 intervention interprets images and information being printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the Samsung Display Workstation contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
- The RAYPAX™ Display Workstation system has been and will be manufactured in 1. accordance with the voluntary standards listed in the enclosed voluntary standard survey.
- The submission contains the results of a hazard analysis and all potential hazards 2. have been classified as Minor.
2
Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
SEP 2 2 1999
Samsung SDS Co., LTD. C/O Mr. Carl Aletto OTECH. Inc. 2001 East Oakshores Drive Aubrey, TX 76227
Re:
K992306 Samsung RAYPAX™ Display Workstation Dated: June 30, 1999 Received: July 9, 1999 Regulatory Class: II (TWO) Product Code: 90 LLZ 21 CFR 892.2050
Dear Mr. Aletto:
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 (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 (Special Controls) or 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 regulation 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 regulations.
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 notification"(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
3
Image /page/3/Picture/0 description: The image shows a grainy, black and white depiction of the letter 'R'. The letter is not solid but appears to be composed of many small, irregularly shaped black dots or specks, giving it a textured or stippled appearance. The background is plain white, providing a stark contrast to the dark letter.
Page 1 of -1
(Indications for Use Form)
510(k) Number:
Device Name:
Samsung SDS Co. Ltd. RAYPAX™ Display Workstation System
Indications for Use:
The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.
The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| ministen Circ
Official | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Annual design of the consideration
------- |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devig
510(k) Number K992346
OR
Prescription Use
(Per 21 CFR 801.109) ✓
Over-The-Counter Use
(Optional Format 1-2-96)