(61 days)
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No
The document describes a medical display monitor and its technical specifications for displaying medical images. There is no mention of AI or ML capabilities for image analysis, processing beyond basic display functions, or diagnostic assistance. The performance studies focus on display characteristics, not algorithmic performance.
No
The device is a display for diagnostic imaging, which aids in diagnosis as an accessory to medical imaging systems, rather than directly providing therapy.
No
The device is a medical display, a monitor used for viewing images, not for performing a diagnostic function itself. The diagnostic function is performed by trained physicians using the images displayed on the monitor.
No
The device description explicitly states it is a "21.3" Color LCD monitor" and describes hardware characteristics like resolution and size. The performance studies also focus on display hardware characteristics.
Based on the provided information, the MD210C3 color display is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "displaying and viewing of digital images for diagnosis by trained physicians." This is related to medical imaging, not the examination of specimens derived from the human body.
- Device Description: It's described as a "21.3" Color LCD monitor that displays image for medical use." This is a display device, not a device used for in vitro testing.
- Input Imaging Modality: The input modalities are CT, MRI, HIS, and PACS, which are all related to medical imaging systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device falls under the category of a medical display used for viewing medical images, which is a different regulatory classification than IVD devices. The mention of "System, Image Processing, Radiological (CLASS II CFR 892.2050)" further supports its classification within the radiological imaging domain.
N/A
Intended Use / Indications for Use
The MD210C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display controllers.
MD210C3 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
Medical Display, MD210C3 is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
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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 physicians / hospital
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)
Display Testing:
- Display Reflection
- Luminance Response
- Luminance Uniformity
- Display Resolution
- Display Noise
- Veiling Glare
- Display Chromaticity
- Miscellaneous Tests
Summary: Test results showed minor differences between MD210C3 and MD211C3, however these differences are minor and were within the acceptable range of DICOM part 14.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a family of three people.
December 10, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NEC Display Solutions, Ltd. % Mr. Tony Hsu Project Engineer Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec.2, Wunhua 1st Road Linkuo, New Taipei City, 24447 TAIWAN
Re: K142951
Trade/Device Name: MD210C3 21.3" Diagnostic Imaging LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 9, 2014 Received: October 16, 2014
Dear Mr. Hsu:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142951
Device Name Medical Display, MD210C3
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The MD210C3 color display is intended to be used for displaying and
viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in
Conjunction with NEC approved display controllers.
MD210C3 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
- Mr. Satoru Kotani Manager NEC Display Solutions Ltd. 4-28, Mita 1-chome, Minato-ku, Tokyo, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393
2. COMPANY REISTRATION NUMBER
3003623028
DATE SUMMARY PREPARED 3.
19 September 2014
4. DEVICE NAME
| Trade Name: | MD210C3 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD210C3 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
| Product Code: | PGY |
PREDICATE DEVICE 4.
MD211C3 3MP Color LCD Monitor by NEC Display Solutions Ltd. (K130770)
ട. DEVICE DESCRIPTION
Medical Display, MD210C3 is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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DEVICE OF INTENDED USE 6.
The MD210C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers.
MD210C3 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
7. SE Comparison Table:
| Items | MD211C3 | MD210C3 |
|---|---|---|
| 510(k) Number | K130770 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.212 mm x 0.212mm |
| Display Color | 1,073,741,824 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:176, V:176 |
| Scanning Frequency | ||
| (H, V) | 31.5-94.8, 126.3kHz , 30, 50-85 Hz | 31.5-94.8, 126.3kHz , 30, 50-85 Hz |
| Native Resolutions | 2048X1536 (Landscape) | |
| 1536X2048 (Portrait) | 2048X1536 (Landscape) | |
| 1536X2048 (Portrait) | ||
| Brightness | 400 cd/m2 calibrated, | |
| 800 cd/m² Max. | 400 cd/m2 calibrated, | |
| 800 cd/m² Max. | ||
| Contrast Ratio | 1400 : 1 (typical) | 1400 : 1 (typical) |
| DOT Clock | 188 MHz | 214.3 MHz |
| Input Signals | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP |
| Input Terminals | DVI-D, Display port | DVI-D, Display port |
| USB (option) / Standard | No | No |
Comparison tables between MD211C3 & MD210C3
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| Active Display Size (H x | Landscape: 433mmX325mm | Landscape: 433mmX325mm |
|---|---|---|
| V) | Portrait: 325X433mm | Portrait: 325X433mm |
| Viewable Image Size | 540 mm (diagonal) | 540 mm (diagonal) |
| Luminance Calibration | Software | Software |
| Default Gamma | 1.8,2.0,2.2 DICOM part 14 | 1.8,2.0,2.2 DICOM part 14 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Input Rating | 1.1-0.4A | 1.1-0.44A |
| Power Save Mode |