(15 days)
Not Found
No
The device description focuses on the physical characteristics and display technology of a medical monitor, with no mention of AI or ML capabilities.
No
The device is a monitor for displaying medical images; it does not directly treat or diagnose a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the monitor is "intended to be used for displaying and viewing of digital images for diagnosis by trained physicians."
No
The device description clearly describes a physical hardware component (a monitor) with a TFT liquid crystal display panel, backlight, inverter, and adjustable stand. 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 the device is a "Monochrome LCD Monitor" intended for "displaying and viewing of digital images for diagnosis." It is a display device, not a test that analyzes biological samples.
- Intended Use: The intended use is to display images for diagnosis, which is a different function than performing a diagnostic test on a biological sample.
While the monitor is used in a diagnostic process (viewing images for diagnosis), it is a tool used in conjunction with diagnostic procedures, not an IVD itself.
N/A
Intended Use / Indications for Use
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The monitor combines a TFT(thin film transistor) liquid crystal display panel structure and a built-in backlight with inverter for a better picture quality.
The monitor can be used in portrait or landscape version, simply by turning the panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. The image brightness can be adjusted by means of a control wheel on the monitor.
The LCD panel adopts Super Fine TFT(SA-SFT) for the MD21GS-2MP-CB, BB and MD211GS2P-CB, BB.
Additionally, a low reflection overcoat is applied on top of the bead layer, which yields a low, uniform reflection over the surface of the glass.
This process also provides for a truer representation of black and a higher contrast ratio.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB can select the use of the landscape or the portrait only by rotating the LCD panel.
The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle,
In addition, because our device has the height adjustment function of the stand, a more ideal positioning can be offered.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB can select the use of 16001200 of the landscape modes or the portrait modes of 12001600 only by rotating the panel equally to the legally marketed device.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB greatly decreases the shift of the Gamma characteristic by the view corner by the wide viewing angle of 178° by the adoption of the latest SA-SFT panel.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB provides support for improved diagnostic accuracy with simultaneous reproduction of up to 1024 from a palette of 3061 possible grayscales.
The 10-bit gamma correction ensures precise and smooth grayscale tuning and better representation of just noticeable difference.
Up to 1024 grayscales can be depicted at the same time for film-less diagnosis.
In The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB, the AC voltage converts into the DC voltage in the device.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB has the insulation structure which meets the standard of UL60601.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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
K06/947
·Section E -
510(k) Summary
E-1. 510(k) Application Date
March, 04. 2006
JUL 25 2006
E-2. Manufacturer
Submitter Name : NEC Display Solutions, Ltd.
Address : 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan
E-3. Contact Person
Name : Shuichi Kino (Mr.)
Manager
Engineering Administration Section, Planning and Administration Department R&D and Product Supply Division
Address : 686-1, Nishioi, Oi-machi, Ashigarakami-gun, Kanagawa, 258-8533 Japan Tel : +81-465-85-2376
Fax : +81-465-85-2378
E-4. Device
Device Name : 21.3inch Monochrome LCD Monitor Model : NEC MD21GS-2MP-CB
NEC MD21GS-2MP-BB
MITSUBISHI MD211GS2P-CB
MITSUBISHI MD211GS2P-BB
These are identical each other, except for mode! designation..
E-5. Common Name
Monochrome LCD Monitor
E-6. Registration Number
Manufacturer: NEC Display Solutions, Ltd. Registration Number: 3003623028 Factory: NPG DISPLAY (DONG GUAN) CO., LTD. Registration Number: 3002808782
1
E-7. Factory
Name : NPG DISPLAY (DONG GUAN) Co., LTD. Address : Jin Xing Industrial Zone, Qing Xi Zhen, Dong Guan, Guang Dong Sheng 511746, P.R. China
E-8. Classification
Device Class : Class II
Classification Name : System, image processing, Radiological Regulation Number : 21 CFR Part 892 Radiology Devices Subpart B Section 892.2050 Device Description : Picture Archiving and Communications System Product code : 90 LLZ
E-9. Reason for Submission
First time submission to market this LCD Monitor as Medical Device in the USA.
E-10. Description of Marketed Device
Device Name : Barco Coronis 2MP Medical Flat Panel Display System
510(k) number : K023322
Intended use :
The Barco Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
Device description :
The monitor combines a TFT(thin film transistor) liquid crystal display panel structure and a built-in backlight with inverter for a better picture quality.
The monitor can be used in portrait or landscape version, simply by turning the panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. The image brightness can be adjusted by means of a control wheel on the monitor.
The 21.3inch Monochrome LOD Monitor has the same intended use, technical characteristics and performance as the legally marketed device (K023322) and thus Substantial Equivalence is given.
2
E-11. Substantial Equivalence Comparison
Device Description :
The LCD panel adopts Super Fine TFT(SA-SFT) for the MD21GS-2MP-CB, BB and MD211GS2P-CB, BB.
Additionally, a low reflection overcoat is applied on top of the bead layer, which yields a low, uniform reflection over the surface of the glass.
This process also provides for a truer representation of black and a higher contrast ratio.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB can select the use of the landscape or the portrait only by rotating the LCD panel.
The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle,
In addition, because our device has the height adjustment function of the stand, a more ideal positioning can be offered.
Please refer to "Table E-11".
Intended Use :
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB are intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
Barco Coronis 2MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
It is intended to be used to support the diagnosis to either device.
Technical Characteristics and performance :
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB can select the use of 16001200 of the landscape modes or the portrait modes of 12001600 only by rotating the panel equally to the legally marketed device.
Barco Coronis 2MP has the viewing angle of 170°.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB greatly decreases the shift of the Gamma characteristic by the view corner by the wide viewing angle of 178° by the adoption of the latest SA-SFT panel.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB provides support for improved diagnostic accuracy with simultaneous reproduction of up to 1024 from a palette of 3061 possible grayscales.
The 10-bit gamma correction ensures precise and smooth grayscale tuning and better representation of just noticeable difference.
Up to 1024 grayscales can be depicted at the same time for film-less diagnosis.
3
The MD21GS-2MP-C8, BB and MD211GS2P-CB, BB are different in the following points compared with the legally marketed device.
Barco Coronis 2MP in difference of built-in circuit of power supply instead of AC adapter.
In Barco Coronis 2MP, the AC voltage converts into the DC voltage with the AC adaptor and is supplied to the device.
In The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB, the AC voltage converts into the DC voltage in the device.
Therefore, the monitor is operated by the dc voltage, and is substantial equivalent to the legally marketed device.
The Barco Coronis 2MP has the insulation structure which meets the standard of UL60950.
However, The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB has the insulation structure which meets the standard of UL60601.
The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB are applied a severer safety standard compared with the legally marketed device.
Therefore, our monitor safety is more excellent than the legally marketed device.
Therefore, The MD21GS-2MP-CB, BB and MD211GS2P-CB, BB are device with higher safety compared with the legally marketed device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 25 2006
NEC Display Solutions, Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K061947
Trade/Device Name: 21.3 inch Monochrome LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 8 2006 Received: July 10, 2006
Dear Mr. Borsai:
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 circular logo with the text "1906-2006 FDA Centennial" inside. The letters "FDA" are prominently displayed in the center of the logo. Three stars are arranged below the word "Centennial".
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/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
·Section D - Indications for use
D-1. Indications for use
INDICATIONS FOR USE
510(K)Number : Not Known
Device Name : 21.3inch Monochrome LCD Monitor
Model : NEC MD21GS-2MP-CB
NEC MD21GS-2MP-BB MITSUBISHI MD211GS2P-CB MITSUBISHI MD211GS2P-B8
Indications for Use :
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Marcel Burdin
(Division Sign-Off) ിന്നും of Reproductive, Abdominal and Radiological Devices 5 10(k) Number
DI