(26 days)
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No
The document describes a medical display system and its components (display, controller board, software) for viewing digital images. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information. The software mentioned is for optimizing display settings, not for image analysis or interpretation using AI/ML.
No
The device is a display system for viewing digital medical images, not for delivering therapy or direct treatment to patients.
No
The device is a display system used for viewing digital images, not for performing diagnosis itself. Its intended use states that it "must not be used in primary image diagnosis in mammography," indicating it's a tool for displaying information to a practitioner who then makes the diagnosis.
No
The device description explicitly states that the system consists of a display (E-2320 C) and a display controller board (BarcoMed 2MP2CFe), in addition to the software (NioWatch). This indicates the presence of hardware components.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the device is a "display system for medical viewing" and is used for "displaying and viewing digital images." It is a hardware and software system designed to present medical images to trained practitioners.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with or analyzing any biological samples from a patient. Its function is solely related to the visual presentation of pre-existing digital images.
- Intended Use: The intended use is for "displaying and viewing digital images for review by trained medical practitioners," which aligns with image display and not diagnostic testing of biological samples.
Therefore, the device described is a medical image display system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Color Nio 2MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The E-2320 C is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
Color Nio 2MP is a display system for medical viewing. It consists of 3 components:E-2320 C is a 20.1" color LCD display. BarcoMed 2MP2CFe is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
E-2320 C is a 20.1" color LCD display for medical viewing. It is combined with NioWatch, a userfriendly software that allows to optimize the display for DICOM-compliant viewing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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1. Date of preparation
NOV 1 6 2005
October 19, 2005
2. Company information
BarcoView 35 President Kennedypark B-8500 Kortriik, 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: Color Nio 2MP .
- 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: Nio 2MP Medical flat panel display system .
- 510(k) number: K042660 .
- Manufacturer: Barco NV .
6. Device description
Color Nio 2MP is a display system for medical viewing. It consists of 3 components:E-2320 C is a 20.1" color LCD display. BarcoMed 2MP2CFe is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
7. Intended use
"The Color Nio 2MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
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8. Summary of technological characteristics
The device consists of three components:
- One 2-megapixel flat panel display (E-2320 C) .
- One 24-bit color display controller (BarcoMed 2MP2CFe board) .
- . NioWatch software
The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape and portrait mode.
The display controller board is an ultra-high speed board with a 32-bit in, 32-bit out look-up table.
The NioWatch 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 display of the Color Nio 2MP system has a color instead of grayscale LCD panel, while screen size and resolution are identical. The display controller board is a color board instead of a grayscale board.
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco Color Nio 2MP is substantially equivalent to the predicate device, Nio 2MP Medical flat panel display system.
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 Color Nio 2MP contains adequate information and data to enable FDA -- CDRH to determine substantial equivalence to the predicate device.
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510(k) Summary In accordance with 21 CFR 807.92
1. Date of preparation
October 19, 2005
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: E-2320 C .
- 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: MFCD 2320 .
- 510(k) number: K040158 .
- Manufacturer: Barco NV .
6. Device description
E-2320 C is a 20.1" color LCD display for medical viewing. It is combined with NioWatch, a userfriendly software that allows to optimize the display for DICOM-compliant viewing.
7. Intended use
The E-2320 C is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
8. Summary of technological characteristics
The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape or
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portrait mode.
The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display information.
Compared to the predicate device, the E-2320 C display contains a backlight sensor instead of a front sensor.
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco E-2320 C is substantially equivalent to the predicate device, MFCD 2320.
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 E-2320 C contains adequate information and rne 520(K) Ne France FDA - CDRH to determine substantial equivalence to the predicate device.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
NOV 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lieven De Wandel BARCOVIEW Medical Imaging Systems 35 President Kennedypark 8500 Kortrijk BELGIUM
Re.: K052958 Trade/Device Name: Color Nio 2MP and E-2320 C Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: October 19, 2005 Received: October 21, 2005
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 (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 (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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you to oogin tuding of substantial equivalence of your device to a legally prematice notification: "The Paris 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, production other general information on your responsibilities under the Act from the 60 : 77). I Canal Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
10(k) Number (if known): المحمد عدد_
Device Name: Color Nio 2MP
Indications for Use:
*The Color Nio 2MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
| 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Gordon
(Division Sign-Of Division of Reproductive, A and Radiological Devices 510(k) Number
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INDICATIONS FOR USE
10(k) Number (if known): مكتوك كلا :
Device Name: E-2320 C
Indications for Use:
"The E-2320 C is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
| Prescription Use | XX |
|---|---|
| ------------------ | ---- |
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
ADD/OR
Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Burleson
(Division Sign-Of Division of Reproductive, Al : Radiolomanal Devices Cik) Number _