MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR

K130772 · Nec Display Solutions , Ltd. · LLZ · Apr 18, 2013 · Radiology

Device Facts

• Record ID: K130772
• Device Name: MD211C2 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 MD211C2 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. MD211C2 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

MD211C2 is a 21.3-inch color LCD monitor for medical diagnostic imaging (CT, MRI, HIS, PACS). It receives digital video input via DVI-D or DisplayPort from NEC-approved display controllers. The device transforms input signals into high-resolution (1600x1200) visual output with adjustable gamma grayscale. Used in clinical environments by physicians to view diagnostic images; output assists in clinical decision-making. Benefits include precise visualization of medical images for diagnosis. Must be interconnected with IEC60601-1-1 certified equipment.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through comparison of technical specifications, safety standards (AAMI/ES 60601-1, EN60601-1-2), and DICOM conformance against the predicate device.

Technological Characteristics

21.3" TFT Color LCD; 1600x1200 resolution; 900 cd/m2 max brightness; 1400:1 contrast ratio. Inputs: DVI-D, DisplayPort (V1.1a). Software-based luminance calibration. Complies with DICOM Part 14, IEC60601-1-1, ANSI/AAMI ES 60601-1:2005, EN60601-1-2, and DIN V 6868-57.

Indications for Use

Indicated for displaying and viewing digital diagnostic images by trained physicians in clinical settings. Contraindicated for 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

• L217TG TFT Color LCD Monitor (K083907)

Submission Summary (Full Text)

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K130772
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# 510(K) Summary of Safety and Effectiveness

As required by 807.92

APR 1 8 2013

#### DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

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

#### DATE SUMMARY PREPARED 3.

12 October 2012

#### 4, DEVICE NAME

| Trade Name: | MD211C2 21.3" Diagnostic Imaging LCD monitor |
|----------------------|---------------------------------------------------------------|
| Model Name: | MD211C2 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CF 892.2050) |

#### 4. PREDICATE DEVICE

L217TG TFT Color LCD Monitor by NEC Display Solutions Ltd. (K083907)

#### DEVICE DESCRIPTION 5.

Medical Display, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) 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 MD211C2 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.

MD211C2 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 | L217TG | MD211C2 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K083907 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270mm |
| Display Color | 16.777,216 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:176, V:176 |
| Scanning Frequency<br>(H, V) | 31.5-91.1kHz , 50-85 Hz | 31.5-74.5, 99.4kHz, 50-85 Hz |
| Native Resolutions | 1600X1200 | 1600X1200 |
| Brightness | 400 cd/m2 calibrated,<br>850 cd/m2 Max. | 400 cd/m2 calibrated,<br>900 cd/m2 Max. |
| Contrast Ratio | 1050 : 1 (typical) | 1400 : 1 (typical) |
| DOT Clock | 162 MHz | 165 MHz |
| Input Signals | Three connectors: one D-sub<br>analog VGA; and two DVI-I<br>(VGA analog or digital) | Two connectors: one DVI-D,<br>one display port (Display port<br>comply with standard V1.1a,<br>applicable to HDCP |
| Input Terminals | DVI-D, D-sub | DVI-D, Display port |
| USB (option) / Standard | No | No |
| Active Display Size (H x V) | Landscape: 432mmX324mm<br>Portrait: 324X432mm | Landscape: 432mmX324mm<br>Portrait: 324X432mm |
| 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, user | 1.8,2.0,2.2 DICOM part 14 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 100W (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:377.6-527.6mm<br>Portrait:483.4-580.7mm<br>D: 227.6 mm |
| NET Weight | 10.7 kg | 11.8 kg |
| Intended of use | Displaying and viewing of digital images for diagnosis by trained physicians<br>This device can not use for a life support system.<br>This device must not be use in digital mammography.<br>This device is designed for exclusive interconnection with IEC60601-1-1certified equipment | Displaying and viewing of digital images for diagnosis by trained physicians<br>This device can not use for a life support system.<br>This device must not be use in digital mammography.<br>This device is designed for exclusive interconnection with IEC60601-1-1certified equipment |
| Certifications &<br>Standards | CE ITE/Medical Device Directive, UL/cUL (UL60601-1, CSA C22.2 No.601-1), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM | CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM |

Comparison tables between MD211C2 & L217TG

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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 L217TG by NEC Display Solutions Ltd. (K083907)

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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. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

Re: K130772

Trade/Device Name: MD211C2 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Jamingh. Messa

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): K130772

Device Name: Medical Display, MD211C2

Indications for Use:

The MD211C2 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.

MD211C2 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)

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

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