(29 days)
Not Found
No
The document describes a diagnostic imaging monitor and does not mention AI or ML capabilities.
No
The device is a display monitor used for viewing images for diagnosis, not for treating any condition.
Yes
The device is a monitor used for displaying digital images for diagnosis by trained physicians, and it is specifically designed for precise diagnostic use in medical imaging modalities like CT, MRI, HIS, and PACS.
No
The device description explicitly states it is a "21.3" Color LCD monitor" and mentions hardware components like the display and resolution.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MDC212C2 Color display is a monitor used for displaying digital images (CT, MRI, etc.) for diagnosis by trained physicians. It is a display device, not a test that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "displaying of digital images for diagnosis," not for performing tests on biological samples.
- Device Description: The description confirms it's a "Diagnostic Imaging Color LCD Monitor" that displays images.
- Input Modality: The input modalities (CT, MRI, HIS, PACS) are imaging modalities, not biological sample analysis methods.
While the device is used in the diagnostic process, it is a tool for viewing images generated by other diagnostic equipment (like CT or MRI scanners), not an in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The MDC212C2 Color displays are intended to be used for displaying 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. MDC212C2 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 IEC 60601-1-1 certified equipment.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1600*1200p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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)
The submission does not contain clinical data. Design Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues.
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.
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
NEC Display Solutions Ltd. % Mr. David Cheng Vice Director Top Victory Electronics (Taiwan) Co., Ltd. 10F, No. 230, Liancheng Road, Zhonghe Dist. New Taipei City, 23559 TAIWAN
Re: K161057
Trade/Device Name: Diagnostic Imaging Color LCD Monitor, Model MDC212C2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 11, 2016 Received: April 14, 2016
Dear Mr. Cheng:
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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. 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,
Michael D.'Hara
For
Robert Ochs, Ph.D. 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)
K161057
Device Name
Diagnostic Imaging Color LCD monitor, Model MDC212C2
Indications for Use (Describe)
The MDC212C2 Color displays are intended to be used for displaying 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.
MDC212C2 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 IEC 60601-1-1 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
[As required by 21 CFR 807.92]
1. Date Prepared
April 12, 2016
2. Submitter's Information
| Name of Sponsor: | NEC Display Solutions Ltd. |
|---|---|
| Address: | 4-28, Mita 1-chome, Minato-ku, |
| Tokyo, Japan. | |
| Contact: | Mr. Satoru Kotani |
| Telephone No.: | +81-465-85-2384 |
| Fax No.: | +81-465-85-2393 |
3. Trade Name, Common Name, Classification
| Trade Name: | Diagnostic Imaging Color LCD Monitor,
Model MDC212C2 |
|----------------------------|---------------------------------------------------------|
| Common Name: | Color LCD Monitor, Color Diagnostic
Display, etc. |
| Classification Name: | System, Image Processing, Radiological |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | II |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows:
| 510(k) Number | K142951 |
|---|---|
| Applicant | NEC Display Solutions Ltd. |
| Device Name | MD210C3 21.3" Diagnostic Imaging LCD monitor |
5. Description of the Device
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1600*1200p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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6. Intended Use
The MDC212C2 Color displays are 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. MDC212C2 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 IEC 60601-1-1 certified equipment.
7. Technological Characteristics
MDC212C2 is a LCD display system for medical viewing, with high resolution 1600 x 1200, self-calibration, Gamma adjust, front sensor, ambient sensor calibration. There are no significant differences between subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
| Item | MDC212C2 |
|---|---|
| Name of device | MDC212C2 |
| Classifications/ code | Class II/ PGY |
| Panel Size and Type | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270mm |
| Display Color | 1,073,741,824 |
| Viewing Angles (°) | H:89, V:89 |
| Scanning Frequency | |
| (H, V) | 31.5-94.0 kHz , 50-85 Hz |
| Brightness | 440 cd/m2 calibrated, |
| 180 cd/m2 Max. | |
| Contrast Ratio | 1500 : 1 (typical) |
| Input Signals | DVI-D (applicable to HDCP) |
| Display Port (applicable to HDCP) | |
| 15pin Mini D-sub | |
| Input Terminals | DVI-D, Display port, VGA |
| USB (option) / Standard | USB Specification Revision 3.0 |
| Active Display Size (H x V) | Landscape: 432mm X 324 mm |
| Portrait: 324 X 432 mm | |
| Viewable Image Size | 540 mm |
| Luminance Calibration | Software |
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| Default Gamma | 1.8,2.0,2.2 DICOM part 14 |
|---|---|
| Power | AC100-240V, 50/60Hz |
| Input Rating | 1.0 - 0.6 A |
8. Substantial Equivalence
The subject device has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Design Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that MDC212C2 is substantially equivalent to predicate devices. Comparative data is shown in Table 1.
9. Summary of Non-clinical Tests
The subject device conforms to the following standards:
- IEC 60601-1. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- o IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- AAPM TG 18. Assessment of Display Performance for Medical Imaging ● Systems
10. Clinical Tests
The submission does not contain clinical data.
11. Conclusion
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Based on the information and non- clinical tests provided in this premarket notification, we conclude that Diagnostic Imaging LCD monitor, Model MDC212C2 is substantially equivalent to predicate devices.
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| Item | Predicate Device K142951 | Subject device |
|---|---|---|
| Name of device | MD210C3 | MDC212C2 |
| Classifications/ code | Class II/ PGY | Class II/ PGY |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.270 mm x 0.270mm |
| Display Color | 1,073,741,824 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:89, V:89 |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 50-85 Hz | 31.5-94.0 kHz, 50-85 Hz |
| Native Resolutions | 2048 x 1536 | 1600 x 1200 |
| Brightness | 400 cd/m2 calibrated, | |
| 800 cd/m2 Max. | 440 cd/m2 calibrated, | |
| 180 cd/m2 Max. | ||
| Contrast Ratio | 1400 : 1 (typical) | 1500 : 1 (typical) |
| DOT Clock | 214.3 MHz | 214.3 MHz |
| Input Signals | DVI-D | |
| Display Port | DVI-D (applicable to HDCP) | |
| Display Port (applicable to HDCP) | ||
| 15pin Mini D-sub | ||
| Input Terminals | DVI-D, Display port | DVI-D, Display port, VGA |
| USB (option) / Standard | No | USB Specification Revision 3.0 |
| Active Display Size (H x V) | Landscape: 433mm x325mm | |
| Portrait: 325X433mm | Landscape: 432mm x 324 mm | |
| Portrait: 324 X 432 mm | ||
| Viewable Image Size | 540 mm | 540 mm |
| 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 | 1.1-0.44A | 1.0 - 0.6 A |
| Dimensions (W x H x D) | W: | |
| Landscape: 467.8mm | ||
| Portrait:361.6 mm | ||
| H: | ||
| Landscape:434.3.6-584.3mm | ||
| Portrait:487.4-637.4mm | ||
| D: 306 mm | W: | |
| Landscape: 466.4 mm | ||
| Portrait: 359.0 mm | ||
| H: | ||
| Landscape: 374.6 - 524.6 mm | ||
| Portrait: 484.0 - 580.0 mm | ||
| D: 227.6 mm | ||
| NET Weight | 11.8 kg | 8.0 kg |
| Intended of use | The MD210C3 color display is | The MDC212C2 Color displays |
| 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. | are 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. | ||
| MDC212C2 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 | ||
| IEC 60601-1-1 certified | ||
| equipment. |
Table 1. Comparative Data
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