(80 days)
Not Found
No
The document describes a medical display system and does not mention AI, ML, or related concepts.
No.
The device is a display system for medical images, intended for review and analysis by medical practitioners, and does not directly provide therapy to a patient.
No
The device is described as a display system for viewing digital images, not for diagnosing conditions. Its intended use is to display and view images for review and analysis, which is a supportive rather than a diagnostic function itself.
No
The device description explicitly states it "consists of components to provide high resolution visualization of digital images," indicating hardware components (the display system itself) are part of the device, not just software.
Based on the provided information, the Nio 5MP Medical Grayscale Display System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for displaying and viewing digital images for review and analysis by medical practitioners. This is a function related to image visualization, not the analysis of biological samples or the diagnosis of conditions based on in vitro tests.
- Device Description: The device is described as a digital image display system. This aligns with its role in presenting images, not performing laboratory tests.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis based on laboratory tests
The device's function is to display medical images, which is a crucial part of the diagnostic process, but it is not performing the in vitro diagnostic test itself. It's a tool used in conjunction with other diagnostic methods.
N/A
Intended Use / Indications for Use
The Barco Nio 5MP Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The Nio 5MP Medical Grayscale Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes
90LLZ
Device Description
The Nio 5MP device is a digital image display system
The Barco Nio 5MP device consists of components to provide high resolution visualization of digital images.
Mentions image processing
System, image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Barco NV Display Systems Coronis 3MP Medical
Flat Panel Display System (K013922)
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
MAR 2 9 2004
:
510(K) SUMMARY
| Manufacturer: | Barco NV Barcoview
Theodoor Sevenslaan 106
8500 Kortrijk
Belgium | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitted By: | Ferguson Medical
Consultant to Barco NV | | |
| Contact Information: | Phone: +32(0) 56 23 32 11
FAX: +32(0) 56 23 3 74 | | |
| Classification Name: | System, image processing | | |
| Common/Usual Name: | Image display system, medical image
workstation, image monitor/display, and others | | |
| Proprietary Name: | Barco Nio 5MP | | |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ | | |
| Substantial Equivalence: | Barco NV Display Systems Coronis 3MP Medical
Flat Panel Display System (K013922) | | |
| Device Description: | The Nio 5MP device is a digital image display
system | | |
| Intended Use: | The Barco Nio 5MP Display System is intended
to be used in displaying and viewing digital
images for review by trained medical
practitioners. | | |
| Technological Characteristics: | The Barco Nio 5MP device consists of
components to provide high resolution
visualization of digital images. | | |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with two snakes winding around it, topped by a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, # 931 ALBUQUERQUE NM 87111
Re: K040040 Trade/Device Name: Nio 5MP Medical Grayscale Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 7, 2003 Received: January 9, 2004
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known): K040040
Device Name: Nio 5MP Medical Grayscale Display System
Indications For Use:
The Nio 5MP Medical Grayscale Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) 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)
| Prescription Use | XX | OR | Over-The- Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, and Radiological Devices | |||
| 510(k) Number | K040040 |