(24 days)
No
The summary describes a medical display with image-enhancing technologies and calibration software, but there is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function. The described technologies appear to be traditional image processing and quality assurance methods.
No
This device is a medical display used for viewing and analyzing medical images, but it does not directly treat or alleviate a disease or condition.
Yes
The device is a medical computer display explicitly designed for "review and analysis by trained medical practitioners" and for "accurate medical image review" to help in making a "swift and accurate diagnosis." It also mentions "image enhancement on diagnostic displays" and the ability to "work with diagnostic images," which directly supports its role in diagnosis.
No
The device description clearly states it is a "medical computer display" and a "high-resolution LCD monitor," which are hardware components. While it mentions optional software, the core device is a physical display.
Based on the provided information, this device 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 trained medical practitioners." This describes a device used to present existing medical images, not a device that performs tests on biological samples to provide diagnostic information.
- Device Description: The description focuses on the technical characteristics of a display monitor (high resolution, luminance, uniformity, stability) and software for quality assurance and image enhancement. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: An IVD device typically involves:
- Analyzing biological samples: Blood, urine, tissue, etc.
- Providing diagnostic information based on the analysis of these samples.
- Reagents or kits for performing tests.
This device is clearly a medical image display, which is a different category of medical device. While it is used in the diagnostic process by allowing medical practitioners to review images, it does not perform the in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
The display is intended to be used for displaying digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes
PGY
Device Description
The Nio Color 8MP (MDNC-8132) is a medical computer display designed for general radiology applications. The device can also be used for home reading in radiology. The display is a high-resolution LCD monitor with characteristics that are important for accurate medical image review: high luminance, good luminance uniformity, good luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightness over the display, noise-free images (=good luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and guidelines. These technologies help the radiologist to make a swift and accurate diagnosis. The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant. The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: - SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. - AAM – Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the high brightness of the diagnostic applications. These applications are addressed by the general term 'Intuitive Workflow Tools'. The integration of the Intuitive Workflow Tools with the displays have been de-risked, verified and validated to ensure that they do not affect the safety and effectiveness of the displays. The display can be used with or without the Barco MXRT display controller boards. The board is installed in a PACS workstation computer, connected to the display. The display can optionally be used with a controlling device (e.g. like a mouse or trackball) that makes it easier to work with diagnostic images and to use the WTs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images (excluding digital mammography)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners / general radiology applications, home reading in radiology
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
Bench tests were performed comparing MDNC-8132 to the cleared device MDNC-2521 as per "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022. The tests included: Spatial resolution MTF, Pixel defects, Artifacts, Temporal Response, Maximum and Minimum Luminance, Luminance response (Conformance to DICOM GSDF), Angular Dependency of Luminance, Luminance uniformity, Reflection coefficient Display Reflectance (including Specular, Diffuse & Haze coefficients), Veiling glare or small-spot contrast, and Color tracking. The tests showed that the MDNC-8132 has similar characteristics compared to the predicate and did not reveal new issues of safety and performance.
Key Metrics
Not Found
Predicate Device(s)
Nio Color 2MP (MDNC-2521) K230520
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Barco N.V. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 KORTRIJK, 8500 BELGIUM
December 11, 2023
Re: K233693
Trade/Device Name: Nio Color 8MP (MDNC-8132) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: November 17, 2023 Received: November 17, 2023
Dear Julie Vandecandelaere:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
| Nio Color 8MP (MDNC-8132) | |
|---|---|
| --------------------------- | -- |
Indications for Use (Describe)
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K233693
| 510(k) Summary | Prepared on: 2023-11-17 | |
|---|---|---|
| -- | ---------------- | ------------------------- |
Contact Details
| Applicant Name | Barco N.V. |
|---|---|
| Applicant Address | President Kennedypark 35 Kortrijk 8500 Belgium |
| Applicant Contact Telephone | +32 (0)56 26 23 |
| Applicant Contact | Ms. Julie Vandecandelaere |
| Applicant Contact Email | julie.vandecandelaere@barco.com |
Device Name
| Device Trade Name | Nio Color 8MP (MDNC-8132) |
|---|---|
| Common Name | Medical image management and processing system |
| Classification Name | Display, Diagnostic Radiology |
| Regulation Number | 892.2050 |
| Product Code | PGY |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| ------------- | ---------------------------------------------------------- | -------------- |
Nio Color 2MP (MDNC-2521) K230520
Device Description Summary
21 CFR 807 92(a)(4)
PGY
4
The No Color 8MP (MDNC-8132) is a medical computer display designed for general radiology applications. The device can also be used for home reading in radiology.
The display is a high-resolution LCD monitor with imarcteristics that are important for accurate medical image review: high luminance, qood luminance uniformity, qood luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightness over the display, noise-free images (=qood luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and quidelines. These technologies help the radiologist to make a swift and accurate diaqnosis.
The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant.
The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays:
-
SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of increasing the contrast in this reqion. Also maqnification and inversion of pixels are possible with SpotView.
-
AAM – Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the high brightness of the diagnostic applications.
These applications are addressed by the general term 'Intuitive Workflow Tools'. The integration of the Intuitive Workflow Tools with the displays have been de-risked, verified and validated to ensure that they do not affect the safety and effectiveness of the displays.
The display can be used with or without the Barco MXRT display controller boards installer board is installed in a PACS workstation computer, connected to the display. The display can optionally be used with is a controlling device (e.g. like a mouse or trackball) that makes it easier to work with diaqnostic images and to use the WTs.
Intended Use/Indications for Use
The display is intended to be used for displaying digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Indications for Use Comparison
The indications for use are the same.
Technological Comparison
21 CFR 807 92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807 92(a)(5)
5
Modifications between MDNC-8132 and MDNC-2521
The modifications are:
-
· New 32″ 8 mega-pixel (3840*2160 resolution) LCD panel
· Updated multimedia board Hera 320D derived from Ares 300D, with similar functionality and design compared to MDNC-2521 (Ares 300D is the multimedia board from MDNC-2521 device) -
Addition of multimedia features (Webcam, speakers and microphone) for easier collaboration
-
External power supply with similar functionality and design principle compared to MDNC-2521
-
Updated display stand, with similar functionality and design principle compared to MDNC-2521
-
New packaging, with similar functionality and design principle compared to MDNC-2521
-
Updated firmware, with similar functionality and design principle compared to the respective predicate devices
The below performance bench tests are performed and corresponding results reported for the modified device MDNC-8132 in comparison to the already cleared device MDNC-2521 as per the Physical Laboratory Testing instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022:
- · Spatial resolution MTF
- Pixel defects, Artifacts
- Temporal Response
- Maximum and Minimum Luminance
- Luminance response, Conformance to DICOM GSDF
- Anqular Dependency of Luminance
- Luminance uniformity
- Reflection coefficient Display Reflectance incl. Specular, Diffuse & Haze coefficients
- Veiling glare or small-spot contrast
- · Color tracking
The tests showed that the MDNC-8132 has similar characteristics compared to already cleared device MDNC-2521 and did not reveal new issues of safety and performance.
Additionally, the MDNC-8132 is compliant to EMC and Safety standards, the environmental tests (climate, mechanical and software tests passed.
No animal testing or clinical testing has been performed.
As a conclusion we can state that the device MDNC-8132 is found to be substantially equivalent to the predicate device MDNC-2521, because:
- The indications for use are the same as the predicate device
- The technological characteristics discussed above do not raise questions of safety and effectiveness
- The bench tests show that the display characteristics are equivalent to those of the predicate device
6
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b)
The below performance bench tests are performed and corresponding results reported for the modified device MDNC-8132 in comparison to the already cleared device MDNC-2521 as per the Physical Laboratory Testing instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022:
- · Spatial resolution MTF
- Pixel defects, Artifacts
- Temporal Response
- Maximum and Minimum Luminance
- Luminance response, Conformance to DICOM GSDF
- Angular Dependency of Luminance
- Luminance uniformity
- · Reflection coefficient Display Reflectance incl. Specular, Diffuse & Haze coefficients
- Veiling glare or small-spot contrast
- Color tracking
The tests showed that the MDNC-8132 has similar characteristics compared to already cleared device MDNC-2521 and did not reveal new issues of safety and performance.
Additionally, the MDNC-8132 is compliant to EMC and Safety standards, the environmental tests (climate, mechanical and software tests passed.
No animal testing or clinical testing has been performed.
As a conclusion we can state that the device MDNC-8132 is found to be substantially equivalent to the predicate device MDNC-2521, because:
- The indications for use are the same as the predicate device
- The technological characteristics discussed above do not raise questions of safety and effectiveness
- The bench tests show that the display characteristics are equivalent to those of the predicate device