(22 days)
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.
Both the Nio Color 2MP (MDNC-2521) and the Nio Color 3MP (MDNC-3521) are medical computer displays designed for general radiology imaging applications.
The MDNC-3521 model can also be used in dental applications.
The devices can also be used for home reading in radiology.
The MDNC-2521 is a derivative of the MDNC-2221.
The MDNC-3521 is a derivative of the MDNC-3421.
The modified displays are effectively identical to the respective predicate devices except for the following changes:
Updated LCD panel with same resolution and dimensions compared to the respective predicate devices New housing, display stand and internal mechanics, with similar functionality and design principle compared to the respective predicate devices Updated internal electronics boards, with similar functionality and design principle compared to the respective predicate devices Updated firmware, with similar functionality and design principle compared to the respective predicate devices New packaging, with similar functionality and design principle compared to the respective predicate devices or any other Barco diagnostic display Rephrasing of the intended usage environment, because of the evolution towards more home reading in radiology Small update in the intended user description The modified device has the following similarities compared to the unmodified device: The same intended use The same operating principle The same fundamental technology
The displays can be used optionally with 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 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 interest and 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.
The provided text describes the acceptance criteria and a study demonstrating that the Barco Nio Color 2MP (MDNC-2521) and Nio Color 3MP (MDNC-3521) displays meet these criteria for substantial equivalence to their predicate devices. The study focuses on physical performance bench tests rather than clinical efficacy with AI or human readers.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the performance bench tests. The Predicate Device columns represent the established performance, which the new devices aim to be substantially equivalent to. The Device for which listing is sought columns show the reported performance of the new devices.
Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance
| Feature/Test | MDNC-2521 (New Device) Performance | MDNC-2221 (Predicate) Performance | MDNC-3521 (New Device) Performance | MDNC-3421 (Predicate) Performance |
|---|---|---|---|---|
| Common Device Parameters | ||||
| Screen technology | IPS-SFT Color LCD | IPS-Pro | IPS-SFT Color LCD | IPS-TFT Color LCD |
| Active screen size (diagonal) | 541 mm (21.3") | 540 mm (21.3") | 541 mm (21.3") | 540 mm (21.3") |
| Active screen size (HxV) | 433 x 325 mm (17.1 x 12.8") | 432 x 324 mm (17.0 x 12.8") | 433 x 325 mm (17.1 x 12.8") | 432 x 324 mm (17.0 x 12.8") |
| Aspect ratio (H:V) | 4:3 | 4:3 | 4:3 | 4:3 |
| Resolution | 2MP (1600 x 1200 pixels) | 2MP (1600 x 1200 pixels) | 3MP (2048 x 1536 pixels) | 3MP (2048 x 1536 pixels) |
| Color imaging | Yes | Yes | Yes | Yes |
| Gray imaging | Yes | Yes | Yes | Yes |
| Bit depth | 30 bit | 30 bit | 30 bit | 30 bit |
| Viewing angle (H, V) | 178° | 178° | 178° | 178° |
| Uniformity Correction | ULT | ULT | ULT | ULT |
| SteadyColor Calibration | Yes (in MXRT Display Controller) | No | Yes (in MXRT Display Controller) | No |
| Ambient Light Compensation (ALC) | Yes, reading room selection | Yes, reading room selection | Yes, reading room selection | Yes, reading room selection |
| Ambient Light Sensor | Yes | Yes | Yes | Yes |
| Front sensor | Yes | Yes | Yes | Yes |
| Maximum luminance (panel typical) | 1000 cd/m² | 800 cd/m² | 1050 cd/m² | 900 cd/m² |
| DICOM calibrated luminance | 600 Cd/m² | 500 cd/m² | 600 Cd/m² | 500 cd/m² |
| Contrast ratio (panel typical) | 2000:1 | 1400:1 | 2000:1 | 1400:1 |
| Response time ((Tr+Tf)/2) (typical) | 12 ms[*] | 10 ms | 12 ms[*] | 20 ms |
| Housing color | Black (RAL 9004) / White (RAL 9003) | RAL 9003 / RAL 9004 | Black (RAL 9004) / White (RAL 9003) | RAL 9003 / RAL 9004 |
| Video input signals | 2x DisplayPort 1.4 | 1x DVI, 1x DisplayPort | 2x DisplayPort 1.4 | DVI-D Dual Link, DisplayPort |
| USB ports | 2x USB-B 2.0 upstream, 5x USB-A 2.0 downstream | 1x USB 2.0 upstream, 2x USB 2.0 downstream | 2x USB-B 2.0 upstream, 5x USB-A 2.0 downstream | 1x USB 2.0 upstream, 3x USB 2.0 downstream |
| Power rating | 24 VDC, 4 A | 24 VDC, 3.75 A | 24 VDC, 4 A | 24 VDC, 4 A |
| Power consumption | 37 W (nominal) | 50 W (nominal) | 45 W (nominal) | 50 W (nominal) |
| Operating temperature | 0 °C to 35 °C (20 °C to 30 °C within specs) | 0 °C to 35 °C (15 °C to 30 °C within specs) | 0 °C to 35 °C (20 °C to 30 °C within specs) | 0 °C to 40 °C (15 °C to 35 °C within specs) |
| Storage temperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C |
| Operating humidity | 8% to 80% (non-condensing) | 8 % to 80 % (non-condensing) | 8% to 80% (non-condensing) | 8 % to 80 % (non-condensing) |
| Storage humidity | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) |
| Minimum operating pressure | 70 kPa minimum | 70 kPa minimum | 70 kPa minimum | 70 kPa minimum |
| Storage pressure | 50 to 106 kPa | 50 to 106 kPa | 50 to 106 kPa | 50 to 106 kPa |
| Bench Tests | ||||
| Spatial resolution – MTF | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Pixel defects, Artifacts | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Temporal Response | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Maximum and Minimum Luminance | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Luminance response, Conformance to DICOM GSDF | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Angular Dependency of Luminance | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Luminance uniformity | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Reflection coefficient | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Veiling glare or small-spot contrast | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Color tracking | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| EMC and Safety standards | Compliant | N/A (implied by predicate) | Compliant | N/A (implied by predicate) |
Note: "Similar characteristics" is the conclusion of the bench tests as stated in the document.
[] The intrinsic response time of the new LCD panel on the modified device is further improved with Barco's RapidFrame technology, a proprietary medical overdrive algorithm which improves the temporal response of the system.*
2. Sample Size Used for the Test Set and Data Provenance
The study described is a series of physical performance bench tests conducted on the device itself and in comparison to predicate devices, rather than a study involving medical images or patient data.
- Sample Size for Test Set: Not applicable in the context of clinical images/data. The tests were performed on the modified devices (MDNC-2521 and MDNC-3521).
- Data Provenance: Not applicable. The "data" here refers to the physical performance measurements of the display hardware.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for display performance parameters (e.g., luminance, resolution) is established by metrology standards and measurement equipment, not by human expert opinion in this context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Physical performance measurements do not inherently require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and substantial equivalence to existing predicate devices based on physical performance.
- Effect Size: Not applicable as no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
- Standalone Performance: Not applicable. The device is a medical computer display, and its performance is assessed based on its physical properties and adherence to display standards, not as an AI algorithm. While it can be optionally used with software like QAWeb Enterprise for calibration and Intuitive Workflow Tools for image enhancement, the submission focuses on the display hardware itself.
7. The Type of Ground Truth Used
The ground truth for this device's evaluation is based on physical measurement standards and the performance specifications of the predicate devices. The "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (issued in 2022) serves as the reference for the physical laboratory testing instructions, which define the expected performance characteristics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a hardware device (display) and not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As this is not an AI algorithm, there is no training set or ground truth established for training purposes.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Barco NV % Ms. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk. W-VL 8500 BELGIUM
March 21, 2023
Re: K230520
Trade/Device Name: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: February 27, 2023 Received: February 27, 2023
Dear Ms. 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 (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 located 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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230520
Device Name Nio Color 2MP (MDNC-2521) Nio Color 3MP (MDNC-3521)
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.
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.
| 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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| 510(k) Summary (in accordance with 21 CFR 807.92) | K230520 | ||
|---|---|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President KennedyparkB-8500 KortrijkBELGIUM | ||
| 2. Contact person | Julie VandecandelaereRegulatory Affairs OfficerTel: +32 (0)56 26 13 19julie.vandecandelaere@barco.com | ||
| 3. Date of submission | 27 February 2023 | ||
| 4. Device information | Trade name/model: Nio Color 2MP (MDNC-2521)Nio Color 3MP (MDNC-3521)Common name: MDNC-2521MDNC-3521Classification name: System, image processing, RadiologicalClassification code: PGYDevice classification: Class 2Regulation number: 892.2050Regulation name: Medical Image Management and Processing System | ||
| 5. Predicate device | MDNC-2521: Nio Color 2MP (MDNC-2221) cleared under 510(K) K133663Common name: MDNC-2221Classification name: System, image processing, RadiologicalClassification code: LLZDevice classification: Class 2Regulation number: 892.2050Regulation name: Medical Image Management and Processing SystemMDNC-3521: Nio Color 3MP (MDNC-3421) cleared under 510(k) K170837Common name: MDNC-3421Classification name: System, image processing, RadiologicalClassification code: PGY | ||
| Device classification: | Class 2 | ||
| Regulation number: | 892.2050 | ||
| Regulation name: | Medical Image Management and Processing System | ||
| 6. Device description | Both the Nio Color 2MP (MDNC-2521) and the Nio Color 3MP (MDNC-3521) are medical computer displays designed for general radiology imaging applications.The MDNC-3521 model can also be used in dental applications.The devices can also be used for home reading in radiology.The MDNC-2521 is a derivative of the MDNC-2221.The MDNC-3521 is a derivative of the MDNC-3421.The modified displays are effectively identical to the respective predicate devices except for the following changes:Updated LCD panel with same resolution and dimensions compared to the respective predicate devices New housing, display stand and internal mechanics, with similar functionality and design principle compared to the respective predicate devices Updated internal electronics boards, with similar functionality and design principle compared to the respective predicate devices Updated firmware, with similar functionality and design principle compared to the respective predicate devices New packaging, with similar functionality and design principle compared to the respective predicate devices or any other Barco diagnostic display Rephrasing of the intended usage environment, because of the evolution towards more home reading in radiology Small update in the intended user description The modified device has the following similarities compared to the unmodified device: The same intended use The same operating principle The same fundamental technology The displays can be used optionally with 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 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 interest and 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. | ||
| 7. Intended Use ofthe Device | 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 ofthe displays.The display can be marketed with or without the Barco MXRT display controller boards.The display controller board is installed in a PACS workstation computer, connected tothe display.MDNC-2521: The display is intended to be used for displaying and viewing digital images(excluding digital mammography) for review and analysis by trained medicalpractitioners. | ||
| MDNC-3521: The display is intended to be used for displaying and viewing digital images(excluding digital mammography) for review and analysis by trained medicalpractitioners. The display may be used in dental applications.Note: There are no changes to the indications for use statement from that of theunmodified device. | |||
| 8. Comparison oftechnologicalcharacteristics | Item | Predicate Device(K133663) | Device for which listing issought |
| Device name | Nio Color 2MP (MDNC-2221) | Nio Color 2MP (MDNC-2521) | |
| Screen technology | IPS-Pro | IPS-SFT Color LCD | |
| Active screen size(diagonal) | 540 mm (21.3") | 541 mm (21.3") | |
| Active screen size(HxV) | 432 x 324 mm (17.0 x 12.8") | 433 x 325 mm (17.1 x 12.8") | |
| Aspect ratio (H:V) | 4:3 | 4:3 | |
| Resolution | 2MP (1600 x 1200 pixels) | 2MP (1600 x 1200 pixels) | |
| Color imaging | Yes | Yes | |
| Gray imaging | Yes | Yes | |
| Bit depth | 30 bit | 30 bit | |
| Viewing angle (H, V) | 178° | 178° | |
| Uniformity Correction | ULT | ULT | |
| SteadyColor Calibration | No | Yes (in MXRT DisplayController), when used as asystem with MXRT DisplayController & QAWebEnterprise | |
| Ambient LightCompensation (ALC) | Yes, reading room selection | Yes, reading room selection | |
| Ambient Light Sensor | Yes | Yes | |
| Front sensor | Yes | Yes | |
| Maximum luminance(panel typical) | 800 cd/m² | 1000 cd/m² | |
| DICOM calibratedluminance | 500 cd/m² | 600 Cd/m² | |
| Contrast ratio (paneltypical) | 1400:1 | 2000:1 | |
| Response time ((Tr +Tf)/2) (typical) | 10 ms | 12 ms[*] (gray-to-grayaverage) | |
| Housing color | RAL 9003 / RAL 9004 | Black (RAL 9004) / White(RAL 9003) | |
| Video input signals | 1x DVI1x DisplayPort | 2x DisplayPort 1.4 | |
| USB ports | 1x USB 2.0 upstream(endpoint)2x USB 2.0 downstream | 2x USB-B 2.0 upstream(endpoint)5x USB-A 2.0 downstream(of which 1 charge port) | |
| Power rating | 24 VDC, 3.75 A | 24 VDC, 4 A | |
| Power consumption | 50 W (nominal)< 1 W (hibernate) | 37 W (nominal)< 0.35 W (hibernate) | |
| Dimensions with stand(W x H x D) | Portrait: 378 x 525 | Portrait: 351 x 531 | |
| Dimensions withoutstand (W x H x D) | Portrait: 378 x 491 x 83 mmLandscape: 491 x 378 x 83mm | Portrait: 351 x 491 x 64 mmLandscape: 491 x 351 x 64mm | |
| Dimensions packaged(W x H x D) | 655 x 388 x 495 mm | 455 x 210 x 770 mm | |
| Net weight with stand | With protective cover: 12.6kgWithout protective cover:11.3 kg | With protective cover: 8.8 kgWithout protective cover: 7.7kg | |
| Net weight withoutstand | With protective cover: 7.6 kgWithout protective cover: 6.3kg | With protective cover: 5.8 kgWithout protective cover: 4.7kg | |
| Net weight packaged | With protective cover: 16.8kg (without optionalaccessories)Without protective cover:15.5 kg (without optionalaccessories) | With protective cover: 12.2kg (without optionalaccessories)Without protective cover:11.2 kg (without optionalaccessories) | |
| Tilt | -5° to +25° | -10° to +30° | |
| Swivel | -30° to +30° | -30° to +30° | |
| Pivot | 90° | 90° | |
| Height adjustmentrange | 100 mm | 100 mm | |
| Mounting standard | VESA (100 mm) | VESA (100 mm) | |
| Screen protection | Protective, anti-reflectiveglass cover (optional) | Protective, anti-reflectivefront glass (optional) | |
| Recommendedmodalities | All digital images, exceptdigital mammography | All digital images, exceptdigital mammography |
BARCO
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Image /page/4/Picture/3 description: The image shows the word "BARCO" in white text on a red background. The letters are in a bold, sans-serif font. To the right of the word "BARCO" is a stylized logo that appears to be a circle with a smaller circle inside, connected by lines.
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Image /page/5/Picture/2 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in BARCO is stylized with a circle and a line extending from it.
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Image /page/6/Picture/3 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. To the right of the word "BARCO" is a symbol that looks like a circle with a line extending from its right side, ending in a small circle.
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| Supplied accessories | |||||
|---|---|---|---|---|---|
| User guide | User guide | ||||
| Documentation disc | Documentation disc | ||||
| System sheet | System sheet | ||||
| Video cable | Video cables | ||||
| Mains cable(s) | USB cables | ||||
| USB cable | Mains cables | ||||
| External power supply | External power supply | ||||
| Optional accessories | Graphics board | Display controller | |||
| QA software | QAWeb | QAWeb | |||
| Warranty | 5 years, including 20000 hrsbacklight warranty | 5 years, including 20000 hrsbacklight warranty | |||
| Operating temperature | 0 °C to 35 °C (15 °C to 30°C within specs) | 0 °C to 35 °C (20 °C to 30°C within specs) | |||
| Storage temperature | -20 °C to 60 °C | -20 °C to 60 °C | |||
| Operating humidity | 8 % to 80 % (non-condensing) | 8% to 80% (non-condensing) | |||
| Storage humidity | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) | |||
| Minimum operatingpressure | 70 kPa minimum | 70 kPa minimum | |||
| Storage pressure | 50 to 106 kPa | 50 to 106 kPa | |||
| Item | Predicate Device(K170837) | Device for which listing issought | |||
| Device name | Nio Color 3MP (MDNC-3421) | Nio Color 3MP (MDNC-3521) | |||
| Screen technology | IPS-TFT Color LCD | IPS-SFT Color LCD | |||
| Active screen size(diagonal) | 540 mm (21.3") | 541 mm (21.3") | |||
| Active screen size(HxV) | 432 x 324 mm (17.0 x 12.8") | 433 x 325 mm (17.1 x 12.8") | |||
| Aspect ratio (H:V) | 4:3 | 4:3 | |||
| Resolution | 3MP (2048 x 1536 pixels) | 3MP (2048 x 1536 pixels) | |||
| Color imaging | Yes | Yes | |||
| Gray imaging | Yes | Yes | |||
| Bit depth | 30 bit | 30 bit | |||
| Viewing angle (H, V) | 178° | 178° | |||
| Uniformity Correction | ULT | ULT | |||
| SteadyColor Calibration | No | Yes (in MXRT DisplayController), when used as asystem with MXRT DisplayController & QAWebEnterprise | |||
| Ambient LightCompensation (ALC) | Yes, reading room selection | Yes, reading room selection | |||
| Ambient Light Sensor | Yes | Yes | |||
| Front sensor | Yes | Yes | |||
| Maximum luminance | 900 cd/m² | 1050 cd/m² | |||
| Color imaging | Yes | Yes | |||
| Gray imaging | Yes | Yes | |||
| Bit depth | 30 bit | 30 bit | |||
| Viewing angle (H, V) | 178° | 178° | |||
| Uniformity Correction | ULT | ULT | |||
| SteadyColor Calibration | No | Yes (in MXRT DisplayController), when used as asystem with MXRT DisplayController & QAWebEnterprise | |||
| Ambient LightCompensation (ALC) | Yes, reading room selection | Yes, reading room selection | |||
| Ambient Light Sensor | Yes | Yes | |||
| Front sensor | Yes | Yes | |||
| Maximum luminance(panel typical) | 900 cd/m² | 1050 cd/m² |
Image /page/7/Picture/2 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in "BARCO" is stylized with a circle and two horizontal lines extending from either side.
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| DICOM calibratedluminance | 500 cd/m² | 600 Cd/m² |
|---|---|---|
| Contrast ratio (paneltypical) | 1400:1 | 2000:1 |
| Response time ((Tr +Tf)/2) (typical) | 20 ms | 12 ms[*] (grey-to-greyaverage) |
| Housing color | RAL 9003 / RAL 9004 | Black (RAL 9004) / White(RAL 9003) |
| Video input signals | DVI-D Dual Link DisplayPort | 2x DisplayPort 1.4 |
| USB ports | 1x USB 2.0 upstream(endpoint)3x USB 2.0 downstream | 2x USB-B 2.0 upstream(endpoint)5x USB-A 2.0 downstream(of which 1 charge port) |
| Power rating | 24 VDC, 4 A | 24 VDC, 4 A |
| Power consumption | 50 W (nominal) | 45 W (nominal)< 0.35 W (hibernate) |
| Dimensions with stand(W x H x D) | Portrait: 378 x 528 | Portrait: 351 x 531 |
| Dimensions withoutstand (W x H x D) | Portrait: 378 x 491 x 84 mmLandscape: 491 x 378 x 84mm | Portrait: 351 x 491 x 64 mmLandscape: 491 x 351 x 64mm |
| Dimensions packaged(W x H x D) | 500 x 280 x 670 mm | 455 x 210 x 770 mm |
| Net weight with stand | With protective cover: 11.2kgWithout protective cover:10.7 kg | With protective cover: 8.8 kgWithout protective cover: 7.7kg |
| Net weight withoutstand | With protective cover: 6.2 kgWithout protective cover: 5.7kg | With protective cover: 5.8 kgWithout protective cover: 4.7kg |
| Net weight packaged | With protective cover: 15.7kg (without optionalaccessories)Without protective cover:15.2 kg (without optionalaccessories) | With protective cover: 12.2kg (without optionalaccessories)Without protective cover:11.2 kg (without optionalaccessories) |
| Tilt | -10° to +30° | -10° to +30° |
| Swivel | -45° to +45° | -30° to +30° |
| Pivot | 90° | 90° |
| Height adjustmentrange | 100 mm | 100 mm |
| Mounting standard | VESA (100 mm) | VESA (100 mm) |
| Screen protection | Protective, anti-reflectiveglass cover (optional) | Protective, anti-reflectivefront glass (optional) |
| Recommendedmodalities | All digital images, exceptdigital mammography | All digital images, exceptdigital mammography |
| Supplied accessories | User guideDocumentation discSystem sheetVideo cableMains cable(s)USB cableExternal power supply | User guideDocumentation discSystem sheetVideo cablesUSB cablesMains cablesExternal power supply |
| Optional accessories | Graphics boardQAWeb | Display controllerQAWeb |
| QA software | QAWeb | |
| Warranty | 5 years, including 20000 hrs backlight warranty | |
| Operating temperature | 0 °C to 40 °C (15 °C to 35 °C within specs) | 0 °C to 35 °C (20 °C to 30 °C within specs) |
| Storage temperature | -20 °C to 60 °C | -20 °C to 60 °C |
| Operating humidity | 8 % to 80 % (non-condensing) | 8% to 80% (non-condensing) |
| Storage humidity | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) |
| Minimum operating pressure | 70 kPa minimum | 70 kPa minimum |
| Storage pressure | 50 to 106 kPa | 50 to 106 kPa |
| [*] The intrinsic response time of the new LCD panel on the modified device is furtherimproved with Barco's RapidFrame technology, a proprietary medical overdrive algorithmwhich improves the temporal response of the system.The technological characteristics shown above show that the devices MDNC-2521 andMDNC-3521 are substantially equivalent to their respective predicate devices MDNC-2221 and MDNC-3421 and they do not reveal new issues of safety and performance. | ||
| 9. Performancetesting | The below performance bench tests are performed and corresponding resultsreported for the modified devices MDNC-2521 and MDNC-3521 in comparison to thealready cleared device MDNC-3421 as per the Physical Laboratory Testinginstructions in "Guidance for Industry and FDA Staff: Display Devices for DiagnosticRadiology", 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 & Hazecoefficients• Veiling glare or small-spot contrast• Color trackingThe tests showed that the modified devices MDNC-2521 and MDNC-3521 have similarcharacteristics compared to already cleared device MDNC-3421 and did not reveal newissues of safety and performance.Additionally, the modified devices MDNC-2521 and MDNC-3521 are compliant to EMCand Safety standards. | |
| 10. Conclusion | The Nio Color 2MP (MDNC-2521) and Nio Color 3MP (MDNC-3521) were found to be substantially equivalent to their respective predicate devices MDNC-2221 and MDNC-3421, due to the following reasons: | |
| a) Device and predicate device have the same intended use respectively | ||
| b) The technological characteristics differences from the predicate device do not affect safety or effectiveness | ||
| c) Bench testing showed that the device has similar characteristics compared to the already cleared device and did not reveal new issues of safety and performance. |
Image /page/8/Picture/3 description: The image shows the word "BARCO" in white letters on a red background. The letters are bold and sans-serif. The "O" in BARCO has a small circle in the middle and a line extending from the right side, resembling a stylized eye or target.
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BARCO
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Image /page/10/Picture/2 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in BARCO is stylized with a circle inside a circle and two horizontal lines extending from the center circle.
§ 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).