(168 days)
Not Found
No
The summary describes a medical display monitor and workstation for viewing digital images, with no mention of AI, ML, or advanced image processing beyond display capabilities. The predicate devices are also monitors and workstations.
No
The device is a monitor intended for displaying and viewing medical images for review and analysis, not for directly treating or diagnosing patients.
No
Explanation: The device is a display monitor used for viewing and analyzing digital images. While it's used by medical practitioners for review and analysis, it does not perform any diagnostic function itself. It simply presents the images for interpretation by a human. The predicate devices also include display monitors and imaging software, further indicating its role as a display tool rather than a diagnostic tool.
No
The device description explicitly states it is a "workstation display" and a "monitor high resolution," indicating it is a hardware device.
Based on the provided information, the Barco MWD 321 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 Barco MWD 321 is described as a "workstation display" and a "monitor" used for "displaying and viewing digital images." Its purpose is to present medical images to trained practitioners for review and analysis.
- Lack of Biological Sample Interaction: The device does not interact with or analyze biological samples. It displays images that are likely generated by other medical devices (imaging modalities).
- Focus on Image Display: The description emphasizes the display and viewing capabilities, not the analysis of biological materials.
Therefore, the Barco MWD 321 falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners.
Product codes
90LMD or 74DXJ
Device Description
The MWD 321 device is a workstation display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
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)
K970999, K885042, K962589, K960911, K962699, K961023, K960613
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.
0
3975
510(k) SUMMARY
JAN - 2 1998
| A. | Manufacturer: | Barco NV/Display Systems
Theodoor Sevenslaan 106
8500 Kortrijk
Belgium |
| ---- | --------------- | --------------------------------------------------------------------------------- |
|---|
Ferguson Medical Submitted By: Consultant to Barco NV
- +32(0)56 23 32 11 Phone: B. Contact Information: +32(0)56 23 3 74 FAX:
- C. System, immage communication Classification Name: (accessory), cathode tube, or, display, ray medical.
Common/usual Name: Workstation, image workstation, and others.
Barco MWD 321 Medical Workstation Proprietary Name: Display
- Classification Number: D. 90LMD or 74DXJ
- E. Substantial Equivalence: Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Medical Systems Division, Sony Sony Trinitron Color Video Monitor PVM-1343MD (K885042), Technology, Aurora Diagnostic Workstation Aurora Inc., Netra Workstation System (K962589), ScImage, and Netra MD Software (K960911), Applicare Medical B.V., Radworks Medical Imaging Software Imaging Accuimage, Inc., Accuimage, (K962699), and Inc. (K961023), Processor GE Medical Image Display Systems, GE Advantage Windows Review Workstation (K960613), and others.
- F. The MWD 321 device is a workstation Device Description: display.
- G. Intended Use: The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners.
- H. Technological Characteristics: The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images.
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 2 1998
Frank Ferguson Official Correspondent Consultant for Barco NV Display Systems 3407 Bay Avenue Chico, California 95973
Re: K972701
Barco MWD 321 Medical Workstation Display Dated: November 12, 1997 Received: November 19, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Ferguson:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (If known):
Barco MWD 321 Medical Workstation Display Qevice Name:
Índications For Use:
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The Barco MWD 321 Medical Workstation is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lichard L. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K972701
Prescription Use √
(Per 21 CFR 801.109)
Over-The-Counter Use _