(15 days)
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No
The document describes a medical display system and associated software for optimizing image viewing. There is no mention of AI, ML, or any related concepts like algorithms for image analysis, diagnosis, or prediction. The "Image Processing" mention is likely related to display optimization for DICOM standards, not AI-driven analysis.
No
The device is a medical display system, not a therapeutic device. Its purpose is to display medical images for review by practitioners, not to treat or therapeutically affect a patient.
No
The device is a display system for viewing medical images, not for making a diagnosis itself. The text explicitly states it "must not be used in primary image diagnosis in mammography."
No
The device description explicitly states it consists of three components: a grayscale LCD display (MFGD 1218), a display controller board (BarcoMed Nio), and software (NioWatch). This includes hardware components, making it not a software-only medical device.
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 E1 Medical Flat Panel Display System and the MFGD 1218 Medical Flat Panel Display are designed for displaying and viewing digital images. They are output devices for medical imaging systems.
- Intended Use: The intended use clearly states they are for "displaying and viewing digital images for review by trained medical practitioners." This is a display function, not a diagnostic test performed on a biological sample.
The device is a medical display system used in conjunction with medical imaging modalities (though the specific modality isn't mentioned, it's implied by the use of digital images). It's part of the workflow for reviewing medical images, but it doesn't perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
The E1 Medical Flat Panel Display System 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)
LLZ
Device Description
E1 is a display system for medical viewing. It consists of 3 components: MFGD 1218 is an 18" 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.
Mentions image processing
System, Image Processing
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2005
Mr. Lieven De Wandel Official Correspondent Barco View Medical Imaging Systems 35 President Kennedypark Kortrijk 8500 BELGIUM
Re: K051201
Trade/Device Name: El Medical Flat Panel Display System and MFGD 1218 Medical Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 29,2005 Received: May 11,2005
Dear Mr. De Wandel:
This letter corrects our substantially equivalent letter of May 26, 2005 regarding the E1 Medical Flat Panel Display System and MFGD 1218 Medical Flat Panel Display. The MFGD 1218 Medical Flat Panel Display was inadvertently left off the original letter. This letter applies to both devices listed above.
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.
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Page 2 - Mr. De Wandel
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 continue 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 (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
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Indications for Use
510(k) Number (if known): K051201
Device Name: E1 MedicalFlat Panel Display System
Indications for Use:
The E1 Medical Flat Panel Display System 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 C. Brogdon
(Division Sign-On)
Division of Reproductive, Abdominal
3
Indications for Use
510(k) Number (if known): K051201
Device Name: MFGD 1218 Medical Flat Panel Display
Indications for Use:
The MFGD 1218 Medical Flat Panel Display 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 C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K051201
510(k) Number
4
510(k) Summary
In accordance with 21 CFR 807.92
1. Date of preparation
April 29, 2005 - Modified May 23, 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: E1 Medical Flat Panel Display System .
- 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
E1 is a display system for medical viewing. It consists of 3 components:
MFGD 1218 is an 18" 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.
7. Intended use
The E1 Medical Flat Panel Display System 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 device consists of three components:
- One 1-megapixel flat panel display (MFGD 1218) 1.
- One 10-bit display controller (BarcoMed Nio board) 2.
- గా NioWatch software
Barco n.v. Pr. Kernedypark 35 B-8500 Kortrijk Beigium Tel.: ; ; 32 56 233 211 · Fax: +32 56 233 457
Image /page/4/Picture/30 description: The image shows a logo for BARCO. The logo is in black and white. The word "BARCO" is in large, bold letters at the top of the image. Below the word "BARCO" is the phrase "visibly yours" in smaller letters.
Page 1 01 2
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The flat panel display has a resolution of 1280 x 1024 pixels. It can be used in landscape mode only.
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 controller information.
Compared to the predicate device, the display from the E1 system has a smaller native resolution and does not contain an internal backlight sensor.
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco E1 Medical Flat Panel Display System 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 E1 Medical Flat Panel Display System contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
Rarca n V Pr. Kennedypark 35 B-8500 Kortrijk, Belgium Tel.: +32 56 233 211 - Fax: +32 56 233 457
Image /page/5/Picture/12 description: The image shows the word "BARCO" in a bold, sans-serif font, with a stylized "O" that resembles a target or a camera lens. Below the word "BARCO", there is a smaller text that reads "visibly yours" in a simple font. The background is black, and the text is white, creating a high contrast.
Page 7 of 2
6
510(k) Summary
In accordance with 21 CFR 807.92
1. Date of preparation
April 29, 2005 - Modified May 23, 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: MFGD 1218 Medical Flat Panel Display .
- 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
MFGD 1218 is an 18″ grayscale LCD display for medical viewing. It is combined with NioWatch, a user-friendly software that allows to optimize the display for DICOMcompliant viewing.
7. Intended use
The MFGD 1218 Medical Flat Panel Display 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 1280 x 1024 pixels. It can be used in landscape mode only.
The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display information.
Compared to the display in the predicate device, the MFGD 1218 display has a smaller native resolution and does not contain an internal backlight sensor.
Page 1 of 2
Pr. Kennervoark 35 B-8500 Kortrijk, Belgium Tel.: +32 56 233 211 - Fax: +32 56 233 457
www.barcomed call.com
SCRCO
Barco D.V.
7
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco MFGD 1218 Medical Flat Panel Display 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 MFGD 1218 Medical Flat Panel Display contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
Image /page/7/Picture/7 description: The image shows the word "BARCO" in a bold, sans-serif font, stacked on top of the phrase "visibly yours" in a smaller, lighter font. The word "BARCO" is in white, set against a black square. The phrase "visibly yours" is also in white, but the background is not as clearly defined. There is a horizontal line to the left of the black square.
Barco n.v Pr. Kennecypark 35 B-8500 Kortrijk, Belgium Tel.: +32 56 233 211 · Fax: +32 56 233 457
visibly yours