(14 days)
No
The document describes a medical display system and its technical specifications, focusing on hardware components and basic QA software. There is no mention of AI, ML, or any related algorithms for image analysis or interpretation.
No
The device is a medical flat panel display system used for viewing and analyzing digital images, not for directly treating or diagnosing medical conditions. It serves as a tool for medical practitioners.
No
The device is a display system used for viewing digital images, not for performing diagnoses itself. Its function is to present images for review and analysis by trained medical practitioners, who then make the diagnosis.
No
The device description explicitly states it consists of an LCD display, an optional display controller board, and QA software, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying and viewing digital images... for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The device is a "high-resolution flat panel LCD display system." This is a display technology, not a diagnostic test kit or instrument that analyzes samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Measurement of biomarkers or analytes
- Diagnostic algorithms based on sample analysis
The device is clearly a medical image display system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Nio 3MP LED (MDNG-3220) Medical Flat Panel 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
PGY
Device Description
The Nio 3MP LED (MDNG-3220) is a high-resolution flat panel LCD display system for reviewing medical images. It consists of an LCD display (MDNG-3220), an optional high-resolution display controller board and QA software. The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant. The display uses LED backlight technology.
Mentions image processing
System, image processing, Radiological
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
The bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device:
Modification to device: LED backlight instead of CCFL
Test performed: Optical tests, DICOM calibration and Luminance Uniformity tests
Criteria: Pass the test
Modification to device: Different platform (including firmware)
Test performed: Functional tests
Criteria: Pass the test
Modification to device: Additional DisplayPort video input
Test performed: Functional tests
Criteria: Pass the test
Modification to device: Front sensor implementation
Test performed: Front sensor qualification test
Criteria: Maximum 5% deviation
Modification to device: Other material of front filter
Test performed: Impact test
Criteria: There shall be no cracking of the enclosure. There shall be no live parts that become accessible.
Modification to device: Other material for sheet metal parts
Test performed: Vibration and drop tests
Criteria: Pass the test
Additional tests performed: EMC test (IEC 60601-1-2)
The tests showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance. Animal or clinical testing have not been performed.
Key Metrics
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Barco N.V. Healthcare Division % Lieven De Wandel 35 President Kennedypark Kortriik B-8500 Belgium
Re: K150821
Trade/Device Name: Nio 3MP LED (MDNG-3220) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 12, 2015 Received: March 27, 2015
Dear Lieven De Wandel:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150821
Device Name Nio 3MP LED (MDNG-3220)
Indications for Use (Describe)
The Nio 3MP LED (MDNG-3220) Medical Flat Panel 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary (in accordance with 21 CFR 807.92) | |||||
|---|---|---|---|---|---|
| 1. Company | Barco N.V. | ||||
| Healthcare Division | |||||
| 35 President Kennedypark | |||||
| B-8500 Kortrijk | |||||
| BELGIUM | |||||
| 2. Contact | |||||
| person | Lieven De Wandel | ||||
| Regulatory Affairs Officer | |||||
| 3. Date of | |||||
| submission | March 12, 2015 | ||||
| 4. Device | |||||
| information | Trade name/model: | ||||
| Common name: | |||||
| Classification name: | |||||
| Classification code: | |||||
| Regulation number: | Nio 3MP LED (MDNG-3220) | ||||
| Nio 3MP LCD display | |||||
| System, image processing, Radiological | |||||
| PGY | |||||
| 892.2050 | |||||
| 5. Predicate | |||||
| device | Nio 3MP (E-3620 MA) cleared under 510(K) K040041 | ||||
| 6. Device | |||||
| description | The Nio 3MP LED (MDNG-3220) is a high-resolution flat panel LCD display system for | ||||
| reviewing medical images. It consists of an LCD display (MDNG-3220), an optional high- | |||||
| resolution display controller board and QA software. | |||||
| The display controller board is installed in a PACS workstation computer, connected to the | |||||
| display. The QA software helps to make and keep the displays DICOM compliant. | |||||
| The display uses LED backlight technology. | |||||
| 7. Intended Use | |||||
| of the Device | The Nio 3MP LED (MDNG-3220) Medical Flat Panel 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. | |||||
| 8. Comparison | |||||
| of technological | |||||
| characteristics | Product acronym | MDNG-3220 | E-3620 MA | ||
| Screen technology | TFT AM LCD Dual Domain | ||||
| IPS | TFT AM LCD Dual Domain | ||||
| IPS | |||||
| Active screen size (diagonal) | 520 mm (20.8") | 528 mm (20.8") | |||
| Active screen size (H x V) | 424 mm x 318 mm | ||||
| (16.69" x 12.52") | 424 x 318 mm (16.7 x | ||||
| 12.5") | |||||
| Aspect ratio (H:V) | 4:3 | 4:3 | |||
| Resolution | 3MP (2048 x 1536) | 3MP (2048 x 1536) | |||
| Pixel pitch | 0.207 mm | 0.207 mm | |||
| Color imaging | No | No | |||
| Gray imaging | Yes | Yes | |||
| Viewing angle (H, V) | 176° | 170° | |||
| Uniform Luminance Technology (ULT) | Yes | Yes | |||
| Per Pixel Uniformity (PPU) | No | No | |||
| Ambient Light Compensation (ALC) | No | No | |||
| Backlight Output Stabilization (BLOS) | Yes | Yes | |||
| I-Guard | Yes | No | |||
| Maximum luminance | 1200 cd/m² | 1000 cd/m² | |||
| DICOM calibrated luminance (ULT off) | 500 cd/m² | 500 cd/m² | |||
| Contrast ratio (typical) | 1200:1 | 900:1 | |||
| Response time (Tr + Tf) | 30 ms | 50 ms | |||
| Scanning frequency (H; V) | 15-129 kHz; 25-98 Hz | 30-124 kHz; 50-85 Hz | |||
| Video input signals | DVI-D Dual Link / | ||||
| DisplayPort | DVI-D Dual Link | ||||
| USB ports | 1 upstream, 2 | ||||
| downstream | 1 upstream, 2 | ||||
| downstream | |||||
| USB standard | 2.0 | 1.1 | |||
| Power requirements (nominal) | 100-240V | 100-240V | |||
| Power consumption (nominal) | 50W | 54W | |||
| Power save mode | Yes | Yes | |||
| Net weight with stand | 13 kg | 13 kg | |||
| Net weight w/o stand | 8 kg | 9 kg | |||
| 9. Performance | |||||
| testing | The bench tests mentioned below were performed to validate the device characteristics | ||||
| that differ from the predicate device: | |||||
| Modification to device | Test performed | Criteria | |||
| LED backlight instead of | |||||
| CCFL | Optical tests, DICOM | ||||
| calibration and Luminance | |||||
| Uniformity tests | Pass the test | ||||
| Different platform (including | |||||
| firmware) | Functional tests | Pass the test | |||
| Additional DisplayPort | |||||
| video input | Functional tests | Pass the test | |||
| Front sensor | |||||
| implementation | Front sensor qualification | ||||
| test | Maximum 5% deviation | ||||
| Other material of front filter | Impact test | There shall be no cracking | |||
| of the enclosure. | |||||
| There shall be no live parts | |||||
| that become accessible. | |||||
| Other material for sheet | |||||
| metal parts | Vibration and drop tests | Pass the test |
BARCO
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BARCO
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| Additional tests performed: EMC test (IEC 60601-1-2) | |
|---|---|
| The tests showed that the device has similar or superior characteristics compared to the | |
| predicate device and did not reveal new issues of safety and performance. | |
| Animal or clinical testing have not been performed. | |
| 10. Conclusion | The Nio 3MP LED (MDNG-3220) was found to be substantially equivalent to the predicate |
| device, due to the following reasons: | |
| a) Device and predicate device have the same intended use | |
| b) The technological characteristics differences from the predicate device do not | |
| affect safety or effectiveness | |
| c) Bench testing showed that the device has similar or superior characteristics | |
| compared to the predicate device and did not reveal new issues of safety and | |
| performance. |
Image /page/5/Picture/2 description: The image shows the word "BARCO" in white text on a black background. The text is in a sans-serif font and is horizontally oriented. To the right of the word "BARCO" is a symbol that resembles a circle with a line extending from the top right.