(68 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 document states the device is a monitor for displaying medical images for diagnosis, not a device used for treating a medical condition.
No
The device is a monitor used for displaying and viewing digital images for diagnosis. It is not the diagnostic device itself, but rather a tool used by trained physicians to aid in diagnosis.
No
The device description clearly details physical hardware components like a TFT liquid crystal display panel, backlight, inverter, and a physical stand with tilt and swivel functions.
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's a display device for medical images, not a test performed on biological samples.
- Intended Use: The intended use is for displaying images for diagnosis by physicians, which aligns with the function of a medical image display, not an IVD.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, sample handling, or analysis of biological specimens, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a medical image display, not an in vitro diagnostic device.
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 21.3inch Monochrome LCD Monitor includes models NEC MD21GS-3MP-CB, NEC MD21GS-3MP-BB, MITSUBISHI MD211GS-3MP-CB, and MITSUBISHI MD211GS3P-BB. These are identical except for model designation. The LCD panel adopts Super Advanced-Super Fine TFT (SA-SFT). 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 monitor can select the use of the landscape or the portrait orientation by rotating the LCD panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. It also has a height adjustment function of the stand. The monitor supports 20481536 resolution in landscape modes or 15362048 in portrait modes. It has a wide viewing angle of 176° due to the adoption of the latest SA-SFT panel. It 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. Unlike the predicate, the subject device has a built-in circuit for power supply, converting AC voltage to DC voltage within the device. The subject device's insulation structure meets the UL60601 standard, which is a severer safety standard compared to the predicate device meeting UL60950.
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 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
DEC 2 7 2005
·Section E -
510(k) Summary
E-1. 510(k) Application Date July 28, 2005
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-3MP-CB NEC MD21GS-3MP-BB MITSUBISHI MD211GS3P-CB
MITSUBISHI MD211GS3P-BB
These are identical each other, except for model 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
E1
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 882,2050 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 3MP Medical Flat Panel Display System
510(k) number : K013922
Intended use :
The Barco Coronis 3MP 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 LCD Monitor has the same intended use, technical characteristics and performance as the legally marketed device (K013922) and thus Substantial Equivalence is given.
2
E-11. Substantial Equivalence Comparison
Device Description :
The LCD panel adopts Super Advanced-Super Fine TFT(SA-SFT) for the MD21GS-3MP-CB, BB and MD211GS3P-CB, BB.
Additionally, a low reflection overooat 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-3MP-CB, BB and MD211GS3P-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-3MP-CB, BB and MD211GS3P-CB, BB are intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
These gray scale display must not be used for primary diagnostic in mammography.
Barco Coronis 3MP 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-3MP-CB, BB and MD211GS3P-CB, BB can select the use of 20481536 of the landscape modes or the portrait modes of 15362048 only by rotating the panel equally to the legally marketed device.
Barco Coronis 3MP has the viewing angle of 170°,
The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB greatly decreases the shift of the Gamma characteristic by the view corner by the wide viewing angle of 176° by the adoption of the latest SA-SFT panel.
The MD21GS-3MP-CB, BB and MD211GS3P-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-3MP-CB, BB and MD211GS3P-CB, BB are different in the following points compared with the legally marketed device.
Barco Coronis 3MP in difference of built-in circuit of power supply instead of AC adapter.
In Barco Coronis 3MP, the AC voltage converts into the DC voltage with the AC adaptor and is supplied to the device.
In The MD21GS-3MP-CB, BB and MD211GS3P-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 3MP has the insulation structure which meets the standard of UL60950.
However, The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB has the insulation structure which meets the standard of UL60601.
The MD21GS-3MP-CB, BB and MD211GS3P-OB, 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-3MP-CB, BB and MD211GS3P-CB, BB are device with higher safety compared with the legally marketed device.
4
Image /page/4/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
NEC-Mitsubishi Electric Visual Systems Corp. c/o Tamas Borsai TÜV Rheinland of North America 12 Commerce RD. NEWTON, CT 06470
Re: K052942 Trade/Device Name: 21.3inch Monochrome LCD Monitor (Models: NEC MD21GS-3MP-CB, NEC MD21GS-3MP-BB, MITSUBISHI MD211GS-3MP-CB, and MITSUBISHI MD211GS-3MP-BB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2005 Received: December 15, 2005
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 the cholosate) to regally mantowa of the Medical Device Amendments, or to devices that have been reay 20, 1770, the chavanentitit 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 do not require approval or a provisions of the Act. The general controls provisions of the Act devices to and got to 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 if your device is olasonia (500 such additional controls. Existing major regulations affecting your Apple rary, it ifaly economic 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 I Toase or advise 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 r oderal hatenents, 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 clectronic 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 early This letter will allow you to ocgin manceme your and a couvalence of your device to a legally market notification. The PDA thing of sabstantial of 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), pleased If you desire specific advice for your device on our laboring 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, please note the regulation entition on your responsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number (800) DIVISIOn of City 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
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-3MP-CB
NEC MD21GS-3MP-BB
MITSUBISHI MD211GS3P-CB
MITSUBISHI MD211GS3P-BB
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)
David A. Lyon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _