(93 days)
Not Found
No
The device description and intended use focus on a medical display system and associated software for image viewing and quality assurance, with no mention of AI or ML capabilities for image analysis or interpretation.
No
The device is described as a display system for viewing and analyzing digital images, not for administering treatment or therapy.
Yes
The device is intended for "review and analysis by trained medical practitioners" of digital images, which is a key part of the diagnostic process, even if it's explicitly stated that it "must not be used in primary image diagnosis in mammography." Its function is to display medical images for professional interpretation, making it a component used in diagnostics.
No
The device description explicitly states that the Nio Fusion 4MP system consists of a display (MDNC 4130), a graphic board (MXRT 2100), and software (MediCal QAWeb). The MDNC 4130 is also marketed separately as a display. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nio Fusion 4MP and MDNC 4130 are described as display systems and displays intended for displaying and viewing digital images. They are used for the review and analysis of these images by medical practitioners.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the human body. Its function is solely related to the visual presentation of existing digital images.
Therefore, the device falls under the category of medical imaging display systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
For Nio Fusion 4MP: "The Nio Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device."
For MDNC 4130: "The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately."
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
MDNC 4130 is a 30" color LCD display for medical viewing. It is combined with MediCal QAWeb, a user-friendly software that allows to optimize the display for DICOM-compliant viewing. The flat panel display panel has a resolution of 2560x1600 pixels. In Single View mode, the display is driven as one 4-megapixel desktop, in DuoView mode, the display is driven via 2 DVI inputs as two separate 2-megapixel desktops. The MediCal QAWeb software allows to set the display function, display test patterns, calibrate, the display and view additional display and display controller information.
Nio Fusion 4MP is a display system for medical viewing. It consists of 3 components: MDNC 4130 is a 30" color LCD display. MXRT 2100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb is a softcopy OA software application for local calibration and QA control. The flat panel display panel has a resolution of 2560x1600 pixels. In Single View mode, the display is driven as one 4-megapixel desktop, in DuoView mode, the display is driven via 2 DVI inputs as two separate 2-megapixel desktops. The MXRT 2100 display controller board is an ultra-high-speed board with a 32-bit out lookup table, providing up to 64 bit color. The MediCal QAWeb software allows to set the display test patterns, calibrate the display and view additional display and display controller information.
Mentions image processing
Yes
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(K) SUMMARY
In accordance with 21 CFR 807.92
1. Date of preparation
`eptember 25, 2006
2. Company information
BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457
3. Contact person
Lieven De Wandel Official correspondent
4. Device information
- . Trade name: MDNC 4130
- . Common name: Display system, medical image workstation, and others
- . Classification name: System, Image Processing
- . Classification number: 21 CFR 892.2050 / Procode 90LLZ
5. Predicate device
:
- . Name: E-2320 C
- . 510(k) number: K052958
- . Manufacturer: Barco NV
6. Device description
MDNC 4130 is a 30" color LCD display for medical viewing. It is combined with MediCal QAWeb, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.
7. Intended use
"The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 4130, which is part of the Nio Fusion 4MP system, will e marketed separately.
8. Summary of technological characteristics
1222965
DEC 2 9 2006
1
The flat panel display panel has a resolution of 2560x1600 pixels. In Single View mode, the display is driven as one 4-megapixel desktop, in DuoView mode, the display is driven via 2 DVI inputs as two separate 2-megapixel desktops.
The MediCal QAWeb software allows to set the display function, display test patterns, calibrate, the display and view additional display and display controller information.
Compared to the predicate device, the MDNC 4130 display uses a larger LCD panel and modified electric circuits. However, the basic functions and intended use of both displays are the same.
The device does not come into contact with the patient. It does not control any life-sustaining devices either.
9. Conclusion:
The Barco MDNC 4130 is substantially equivalent to the predicate device, E-2320 C. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.
Any difference between both devices does not affect safety or efficacy.
The 510(k) Pre-Market Notification for the Barco MDNC 4130 contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
2
510(K) SUMMARY
In accordance with 21 CFR 807.92
1. Date of preparation
September 25, 2006
2. Company information
BarcoView
35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457
3. Contact person
Lieven De Wandel Official correspondent
4. Device information
- . Trade name: Nio Fusion 4MP
- Common name: Display system, medical image workstation, and others ●
- Classification name: System, Image Processing .
- Classification number: 21 CFR 892.2050 / Procode 90LLZ �
5. Predicate device
- . Name: Color Nio 2MP
- . 510(k) number: K052958
- . Manufacturer: Barco NV
6. Device description
Nio Fusion 4MP is a display system for medical viewing. It consists of 3 components: MDNC 4130 is a 30" color LCD display. MXRT 2100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb is a softcopy OA software application for local calibration and QA control.
7. Intended use
The Nio Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
3
8. Summary of technological characteristics
The device consists of three components:
- . One 4-megapixel flat panel display (MDNC 4130)
- . One 32-bit display controller (MXRT 2100 board)
- . MediCal QAWeb software
The flat panel display panel has a resolution of 2560x1600 pixels. In Single View mode, the display is driven as one 4-megapixel desktop, in DuoView mode, the display is driven via 2 DVI inputs as two separate 2-megapixel desktops.
The MXRT 2100 display controller board is an ultra-high-speed board with a 32-bit out lookup table, providing up to 64 bit color.
The MediCal QAWeb software allows to set the display test patterns, calibrate the display and view additional display and display controller information.
Compared to the predicate device, the display of the Nio Fusion 4MP system uses a larger LCD panel and modified electric circuits. The display controller board is also different. The accompanying software application has a more advanced functionality. However, the basic functions and intended use of both systems are the same.
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco Nio Fusion 4MP is substantially equivalent to the predicate device, Color Nio 2MP. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.
Any difference between both devices does not affect safety or efficacy.
The 510(k) Pre-Market Notification for the Barco Nio Fusion 4MP contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC 2 9 2006
Mr. Lieven De Wandel Official Correspondent BarcoView 35 President Kennedy Park 8500 Kortrijk BELGIUM
Re: K062905
Trade/Device Name: Nio Fusion 4MP and MDNC 4130 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2006 Received: December 18, 2006
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/4/Picture/10 description: The image shows a black and white logo for the FDA Centennial, celebrating the years 1906-2006. The logo is circular, with text around the perimeter. In the center, the letters 'FDA' are prominently displayed above the word 'Centennial'. Below 'Centennial' are three stars.
Protecting and Promoting Public Health
5
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): K062905
Device Name: Nio Fusion 4MP
Indications for Use:
"The Nio Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device.
Prescription Use XX
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off)
ductive, Abdom n of Renro Radiological Devices 510(k) Number
7
INDICATIONS FOR USE
510(k) Number (if known): __
Device Name: MDNC 4130
Indications for Use:
"The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately.
Prescription Use XX (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Si Division of Reproductive. Abdomina Radiological Device 510(k) Number