(35 days)
Not Found
No
The document describes a medical display system and its components (display, controller board, software) for viewing medical images. There is no mention of AI or ML in the intended use, device description, or any other section. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a display system used for viewing digital images and does not directly provide therapy or treatment.
No
The device is a display system for viewing digital images, not for performing primary image diagnosis. It explicitly states it "must not be used in primary image diagnosis in mammography."
No
The device description explicitly states that the system consists of hardware components: a grayscale LCD display (E-3621) and a display controller board (BarcoMed Nio). While it includes software (NioWatch), it is not solely 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 description clearly states that the device is a display system 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 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 Nio 3MP-21 and E-3621, as described, fall under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
"The Nio 3MP-21" 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-3621 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
Nio 3MP-21" is a display system for medical viewing. It consists of 3 components: E-3621 is a 21" grayscale LCD display. BarcoMed Nio 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-3621 is a 21" grayscale 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
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 (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
K05190L
510(k) Summary In accordance with 21 CFR 807.92
1. Date of preparation
AUG 1 7 2005
July 05, 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: Nio 3MP-21" ~ �
- 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 V �
- Manufacturer: Barco NV .
6. Device description
Nio 3MP-21" is a display system for medical viewing. It consists of 3 components:
E-3621 is a 21" grayscale LCD display. BarcoMed Nio 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 Nio 3MP-21" 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 3-meqapixel flat panel display (E-3621) .
- . One 10-bit display controller (BarcoMed Nio board)
- . NioWatch software
The flat panel display has a resolution of 2048x1536 pixels. It can be used in landscape and portrait mode.
The display controller board is an ultra-high speed board with an 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray.
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 from the Nio 3MP-21" system has a different LCD panel with somewhat larger screen size and higher resolution. The other components of the system 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 3MP-21" 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 Nio 3MP-21" 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
July 05, 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-3621 .
- 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: MFGD 2320 20-inch 2 Megapixel grayscale display .
- 510(k) number: K033004 ~ .
- Manufacturer: Barco NV .
6. Device description
E-3621 is a 21" grayscale 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-3621 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 2048x1536 pixels. It can be used in landscape on
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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-3621 display has a different LCD panel with larger screen size and higher resolution, and 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-3621 is substantially equivalent to the predicate device, MFGD 2320 20-inch 2 Megapixel grayscale display.
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-3621 contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
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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 extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lieven De Wandel Official Correspondent Barco-Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM
Re: K051901
AUG 1 7 2005
Trade/Device Name: Nio 3MP-21 Medical Flat Panel Display System and E-3621 Medical Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: July 5, 2005 Received: July 13, 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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to organization of substantial equivalence of your device to a legally prematics notifiedding - 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 rr you don't if you 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 807.97). You may obtain other general information on your responsibilities under the Act from the 001:57). I od may overnmentional 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): ----------------
Device Name: E-3621
Indications for Use:
"The E-3621 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 (21 CFR 801 Subpart C)
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 bragdon
(Division Sign Off Division of Reproduct and Radiological Devices 510(k) Number