(15 days)
No
The summary describes a medical display system and its modifications, focusing on hardware and firmware updates for image display. There is no mention of AI/ML algorithms for image analysis or processing.
No.
The device is a display system for viewing digital images, intended for review and analysis by medical practitioners. It does not exert any direct therapeutic action or deliver treatment to a patient.
No
The device is a medical flat panel display system intended for displaying and viewing digital images for review and analysis, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components (PLD panel, metal housing, packaging) and mentions hardware-specific modifications and testing (environmental tests, electrical safety, EMC). While it has updated firmware, it is fundamentally a hardware display system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The Nio Color 3MP LED Medical Flat Panel Display System is a display. Its function is to display and view digital images. It does not analyze biological specimens or perform any tests on samples taken from the body.
- Intended Use: The intended use is for "displaying and viewing digital images... for review and analysis by trained medical practitioners." This clearly describes a display device for medical imaging, not an IVD.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVDs.
Therefore, based on the provided information, this device is a medical display, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nio Color 3MP LED Medical Flat Panel Display System 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.
Product codes
PGY
Device Description
The MDNC-3421 is a derivative of the MDNC-3321. The modifications are:
✓ PLD panel instead of NLT panel
✓ Change in packaging (smaller size)
✓ Updated firmware
✓ Change in type of material from steel to aluminum (inside metal housing)
✓ For the dental radiology market, this display will be marketed with the screen in landscape orientation
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
The bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device:
- Modification to device: PLD panel instead of NLT panel. Test performed: PPVR (Product Producibility Validation Report).
- Modification to device: Change in packaging (smaller size). Test performed: Environmental tests.
- Modification to device: Updated firmware. Test performed: Firmware tests.
- Modification to device: Change in type of material from steel to aluminum (inside metal housing). Test performed: Environmental tests.
- Modification to device: For the dental radiology market, this display will be marketed with the screen in landscape orientation and for general radiology, this display will be marketed in portrait orientation. Test performed: Clinical study.
Additional tests performed: Electrical Safety test (IEC 60601-1), 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 testing has not been performed.
Key Metrics
Not Found
Predicate Device(s)
Nio Color 3MP (MDNC-3321) cleared under 510(K) K131295
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Barco NV % Ms. Helena Soenen Regulatory Affairs Officer President Kennedypark 35 Kortriik 8500 BELGIUM
Re: K170837
Trade/Device Name: Nio Color 3MP (MDNC-3421) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 15, 2017 Received: March 21, 2017
Dear Ms. Soenen:
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.
1
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/Resourcesfor You/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.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170837
Device Name Nio Color 3MP (MDNC-3421)
Indications for Use (Describe)
The Nio Color 3MP LED Medical Flat Panel Display System 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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 | Helena Soenen | ||||||||||||||||||||||||||||||
| Regulatory Affairs Officer | |||||||||||||||||||||||||||||||
| 3. Date of submission | 15 March 2017 | ||||||||||||||||||||||||||||||
| 4. Device information | Trade name/model: Nio Color 3MP (MDNC-3421) | ||||||||||||||||||||||||||||||
| Common name: MDNC-3421 | |||||||||||||||||||||||||||||||
| Classification name: System, image processing, Radiological | |||||||||||||||||||||||||||||||
| Classification code: PGY | |||||||||||||||||||||||||||||||
| Regulation number: 892.2050 | |||||||||||||||||||||||||||||||
| 5. Predicate device | Nio Color 3MP (MDNC-3321) cleared under 510(K) K131295 | ||||||||||||||||||||||||||||||
| 6. Device description | The MDNC-3421 is a derivative of the MDNC-3321. The modifications are: | ||||||||||||||||||||||||||||||
| ✓ PLD panel instead of NLT panel | |||||||||||||||||||||||||||||||
| ✓ Change in packaging (smaller size) | |||||||||||||||||||||||||||||||
| ✓ Updated firmware | |||||||||||||||||||||||||||||||
| ✓ Change in type of material from steel to aluminum (inside metal housing) | |||||||||||||||||||||||||||||||
| ✓ For the dental radiology market, this display will be marketed with the screen in landscape orientation | |||||||||||||||||||||||||||||||
| 7. Intended Use of the Device | The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | ||||||||||||||||||||||||||||||
| 8. Comparison of technological characteristics | Specification MDNC-3421 MDNC-3321 Screen technology TFT AM Color LCD IPS TFT AM Color LCD IPS Active screen size (diagonal) 540 mm (21.3") 540 mm (21.3") Active screen size (H x V) 433 x 325 mm (17.0 x 12.8") 433 x 325 mm (17.0 x 12.8") Aspect ratio (H:V) 4:3 4:3 Resolution 3MP (2048 x 1536) 3MP (2048 x 1536) Pixel pitch 0.2155 mm 0.2155 mm Color imaging Yes Yes Gray imaging Yes Yes Viewing angle (H, V) 176° 176° |
BARCO
4
| Uniform Luminance
| Technology (ULT) | Yes | Yes |
|---|---|---|
| Per Pixel Uniformity (PPU) | No | No |
| Ambient Light Compensation | ||
| (ALC) | No | No |
| Backlight Output Stabilization | ||
| (BLOS) | Yes | Yes |
| Maximum luminance | 800 cd/m² | 800 cd/m² |
| DICOM calibrated luminance | ||
| (ULT off) | 400 cd/m² | 400 cd/m² |
| Contrast ratio (typical) | 1400:1 | 1400:1 |
| Response time (Tr + Tf) | 40 ms | 40 ms |
| Video input signals | DVID Dual Link, DisplayPort | DVID Dual Link, DisplayPort |
| USB ports | 1 upstream (endpoint), 2 downstream | 1 upstream (endpoint), 2 downstream |
| USB standard | 2.0 | 2.0 |
| Power consumption (nominal) | 50W | 50W |
| Power save mode | Yes | Yes |
| Dimensions with stand (W x H x D) | Portrait: 378 x 528~628 x 235 mm | |
| Landscape: 491 x 472~572 x 235 mm | Portrait: 378 x 528~628 x 235 mm | |
| Landscape: 491 x 472~572 x 235 mm | ||
| Dimensions w/o stand (W x H x D) | Portrait: 378 x 491 x 84 mm | |
| Landscape: 491 x 378 x 84 mm | Portrait: 378 x 491 x 84 mm | |
| Landscape: 491 x 378 x 84 mm | ||
| Net weight with stand | 12.8 kg | 12.8 kg |
| Intended use | The Nio Color 3MP LED | |
| Medical Flat Panel Display | ||
| System is intended to be used | ||
| for displaying and viewing | ||
| digital images (excluding | ||
| digital mammography) for | ||
| review and analysis by trained | ||
| medical practitioners. | The Nio Color 3MP LED | |
| Medical Flat Panel Display | ||
| System is intended to be used | ||
| for displaying and viewing | ||
| digital images (excluding | ||
| digital mammography) for | ||
| review and analysis by trained | ||
| medical practitioners. | ||
| 9. Performance | ||
| The bench tests mentioned below were performed to validate the device characteristics | ||
| that differ from the predicate device: | ||
| testing | ||
| Modification to device | Test performed | |
| PLD panel instead of NLT panel | PPVR (Product Producibility Validation | |
| Report) | ||
| Change in packaging (smaller size) | Environmental tests | |
| Updated firmware | Firmware tests | |
| Change in type of material from steel to | ||
| aluminum (inside metal housing) | Environmental tests | |
| For the dental radiology market, this | ||
| display will be marketed with the screen | Clinical study | |
| in landscape orientation and for general | ||
| radiology, this display will be marketed in | ||
| portrait orientation. | ||
| Additional tests performed: Electrical Safety test (IEC 60601-1), 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 testing has not been performed. | ||
| 10. Conclusion | The Nio Color 3MP 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. |
BARCO
5
Image /page/5/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. The "R" and "C" in "BARCO" are stylized, with the top right of the "R" and the top left of the "C" forming a connected shape.