MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR

K130770 · Nec Display Solutions , Ltd. · LLZ · Apr 18, 2013 · Radiology

Device Facts

• Record ID: K130770
• Device Name: MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
• Applicant: Nec Display Solutions , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The MD211C3 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. MD211C3 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.

Device Story

MD211C3 is a 21.3-inch color TFT LCD monitor providing 3-megapixel (2048x1536) resolution for medical imaging (CT, MRI, HIS, PACS). Device receives digital video input via DVI-D or DisplayPort from NEC-approved display controllers. It transforms input signals into calibrated grayscale or color images using adjustable gamma settings. Operated by trained physicians in clinical environments for diagnostic review. Output allows visualization of medical images to support clinical decision-making. Device requires exclusive interconnection with IEC60601-1-1 certified equipment.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical safety, mechanical safety, and DICOM conformance.

Technological Characteristics

21.3" TFT Color LCD; 2048x1536 resolution; 10-bit color depth; 1400:1 contrast ratio; DVI-D and DisplayPort inputs; software-based luminance calibration; DICOM Part 14 gamma compliance; AC100-240V power; compliant with ANSI/AAMI ES 60601-1:2005 and EN60601-1-2.

Indications for Use

Indicated for displaying and viewing digital medical images for diagnosis by trained physicians. Contraindicated for use in life-support systems and digital mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• L218TL 3MP Monochrome LCD Monitor (K090215)

Submission Summary (Full Text)

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K130770
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# 510(K) Summary of Safety and Effectiveness

APR 1 8 2013

As required by 807.92

#### 1. DEVICE ESTABLISHMENT AND CONTACT PERSON

Mr. Satoru Kotani Manager NEC Display Solutions Ltd. 4-28, Mita 1-chome, Minato-ku, Tokyo, Japan Ph: [phone] Fax: [phone]

### 2. COMPANY REISTRATION NUMBER 3003623028

#### 3. DATE SUMMARY PREPARED

12 October 2012

#### 4. DEVICE NAME

| Trade Name: | MD211C3 21.3" Diagnostic Imaging LCD monitor |
|----------------------|----------------------------------------------------------------|
| Model Name: | MD211C3 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |

#### 4. PREDICATE DEVICE

L218TL 3MP Monochrome LCD Monitor by NEC Display Solutions Ltd. (K090215)

#### 5. DEVICE DESCRIPTION

Medical Display, MD211C3 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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#### 6. DEVICE OF INTENDED USE

The MD211C3 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.

MD211C3 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:

### Comparison tables between MD211C3 & L218TL

| Items | L218TL | MD211C3 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K090215 | |
| Panel Size and Type | 21.3" TFT Monochrome LCD<br>Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.212 mm x 0.212mm |
| Display Color | 10-bit (1024 grey tones) with 3061<br>total colors | 1,073,741,824 |
| Viewing Angles (") | H:176, V:176 | H:176, V:176 |
| Scanning Frequency<br>(H, V) | 31.5-95.4kHz , 30, 50-85 Hz | 31.5-94.8, 126.3kHz , 30, 50-85 Hz |
| Native Resolutions | 2048X1536 (Landscape)<br>1536X2048 (Portrait) | 2048X1536 (Landscape)<br>1536X2048 (Portrait) |
| Brightness | 400 cd/m² calibrated,<br>1450 cd/m² Max. | 400 cd/m² calibrated,<br>800 cd/m² Max. |
| Contrast Ratio | 900 : 1 (typical) | 1400 : 1 (typical) |
| DOT Clock | 162 MHz | 188 MHz |
| Input Signals | Two connectors: one D-sub analog<br>VGA; and one DVI-I (VGA<br>analog or digital) | Two connectors: one DVI-D,<br>one display port (Display port<br>comply with standard VI.1a |
| | | applicable to HDCP |
| Input Terminals | DVI-D, D-sub | DVI-D, Display port |
| USB (option) / Standard | No | No |
| Active Display Size (H x<br>V) | Landscape: 433mmX325mm<br>Portrait: 325X433mm | Landscape: 433mmX325mm<br>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 + off,<br>user | 1.8,2.0,2.2 DICOM part 14 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 98W (Max) | 88W (Max) |
| Power Save Mode | <2W | <2W |
| Dimensions<br>(W x H x D) | W:<br>Landscape: 467.8mm<br>Portrait:361.6 mm<br>H:<br>Landscape: 434.3-584.3mm<br>Portrait: 487.4-637.4mm<br>D: 306 mm | W:<br>Landscape: 467.8mm<br>Portrait:361.6 mm<br>H:<br>Landscape:434.3-584.3mm<br>Portrait:487.4-637.4mm<br>D: 306 mm |
| NET Weight | 10.7 kg | 11.8 kg |
| Intended of use | Displaying and viewing of digital<br>images for diagnosis by trained<br>physicians<br>This device can not use for a life<br>support system.<br>This device must not be use in<br>digital mammography.<br>This device is designed for<br>exclusive interconnection with<br>IEC60601-1-1certified equipment | Displaying and viewing of<br>digital images for diagnosis by<br>trained physicians<br>This device can not use for a life<br>support system.<br>This device must not be use in<br>digital mammography.<br>This device is designed for<br>exclusive interconnection with<br>IEC60601-1-1certified<br>equipment |
| Certifications &<br>Standards | CE ITE/Medical Device Directive,<br>UL/cUL (UL60601-1, CSA C22.2<br>No.601-1), FCC Class B,<br>EN60601-1-2, DIN V 6868-57,<br>DICOM | CE ITE/Medical Device<br>Directive, UL/cUL<br>(ANSI/AAMI ES<br>60601-1:2005), FCC Class B,<br>EN60601-1-2, DIN V 6868-57,<br>DICOM |

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#### 8. CONCLUSION

These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (AAMI/ES 60601-1) human factors and DICOM conformance. It use similar material, and have same compatibility with environment and other device. Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to L218TL by NEC Display Solutions Ltd. (K090215)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol featuring three overlapping, curved lines that resemble a caduceus without the snake.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 18, 2013

NEC Display Solutions, Ltd. % Mr. Jeffrey D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. l 2 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

Re: K130770

Trade/Device Name: MD211C3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 6, 2013 Received: April 3, 2013

Dear Mr. Rongero:

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 (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 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.

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Page 2 - Mr. Rongero

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jamingh. M. Mange

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

K130770 510(k) Number (if known):

Device Name: Medical Display, MD211C3

Indications for Use:

The MD211C3 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.

MD211C3 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.

Prescription Use · V (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ramingh. Messo

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

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