MD322C8 31.5 Diagnostic Imaging LCD Monitor

K150145 · Nec Display Solutions , Ltd. · PGY · Feb 6, 2015 · Radiology

Device Facts

• Record ID: K150145
• Device Name: MD322C8 31.5 Diagnostic Imaging LCD Monitor
• Applicant: Nec Display Solutions , Ltd.
• Product Code: PGY · Radiology
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Indications for Use

The MD322C8 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. MD322C8 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

The MD322C8 is a 31.5-inch color LCD monitor for medical diagnostic imaging. It receives digital image data from NEC-approved display controllers via DVI-D or DisplayPort interfaces. The device transforms these inputs into high-resolution (3840x2160p) visual outputs with adjustable gamma grayscale, compliant with DICOM Part 14 standards. Used in clinical environments (e.g., radiology departments, hospitals) by trained physicians, the monitor facilitates the viewing of CT, MRI, HIS, and PACS images. The output allows clinicians to perform diagnostic assessments. The device benefits patients by providing high-fidelity, calibrated visual representations of medical imaging data, supporting accurate clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated through display reflection, luminance response, luminance uniformity, resolution, noise, veiling glare, and chromaticity tests. Results confirmed that performance differences between the subject and predicate device are minor and within acceptable DICOM Part 14 ranges.

Technological Characteristics

31.5-inch TFT Color LCD monitor; 3840x2160p native resolution; 1000:1 contrast ratio; 400 cd/m2 calibrated luminance. Connectivity via DVI-D and DisplayPort (V1.1a). Software-based luminance calibration. Compliant with ANSI/AAMI ES 60601-1, EN60601-1-2, and DICOM Part 14. Power: AC100-240V, 50/60Hz.

Indications for Use

Indicated for trained physicians to display and view digital images for diagnostic purposes in clinical settings (CT, MRI, HIS, PACS). 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

• MD210C3 3MP Color LCD Monitor (K142951)

Submission Summary (Full Text)

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February 6, 2015

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 Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec 2, Wunhua 1st Road, Linkuo, New Taipei City, 24447 TAIWAN

Re: K150145

Trade/Device Name: 31.5 inch Color LCD Monitor MD322C8 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 15, 2015 Received: January 22, 2015

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, 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 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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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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) K150145

Device Name Medical Display, MD322C8

| Indications for Use (Describe) | |
|--------------------------------|--|
|--------------------------------|--|

The MD322C8 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.

MD322C8 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: [phone] Fax: [phone]
#### 2. COMPANY REISTRATION NUMBER

3003623028

#### DATE SUMMARY PREPARED 3.

15th January 2015

#### 4. DEVICE NAME

| Trade Name: | MD322C8 31.5" Diagnostic Imaging LCD monitor |
|----------------------|-------------------------------------------------------------------|
| Model Name: | MD322C8 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR<br>892.2050) |
| Product Code: | PGY |

#### PREDICATE DEVICE 4.

MD210C3 3MP Color LCD Monitor by NEC Display Solutions Ltd. (K142951)

#### ട. DEVICE DESCRIPTION

Medical Display, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p 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 MD322C8 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.

MD322C8 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 | MD210C3 | MD322C8 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K142951 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 31.5" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.182 mm x 0.182mm |
| Display Color | 1,073,741,824 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:178, V:178 |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 30, 50-85 Hz | 31.5-133.2kHz, 24-87 Hz |
| Native Resolutions | 2048X1536 (Landscape)<br>1536X2048 (Portrait) | 3840X2160 (Landscape)<br>2160X3840 (Portrait) |
| | Brightness | 400 cd/m2 calibrated,<br>800 cd/m² Max. |
| Contrast Ratio | 1400 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 214.3 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 |
| Active Display Size (H x<br>V) | Landscape: 433mmX325mm<br>Portrait: 325X433mm | Landscape: 697.9mmX392.6mm<br>Portrait: 392.6X697.9mm |
| Viewable Image Size | 540 mm (diagonal) | 801 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 | 1.1-0.44A | 1.51-0.6A |
| Power Save Mode | <2W | <5W |
| Dimensions<br>(W x H x D) | W:<br>Landscape: 473mm<br>Portrait:373.4 mm<br>H:<br>Landscape:393.6-543.6mm<br>Portrait:490.6-593.4mm<br>D: 235.5 mm | W:<br>Landscape: 744.8mm<br>Portrait:440.8 mm<br>H:<br>Landscape:463.4-613.4mm<br>Portrait:707.1-737.0mm<br>D: 301.6 mm |
| NET Weight | 11.8 kg | 17 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 (ANSI/AAMI ES<br>60601-1:2005), 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. |

### Comparison tables between MD210C3 & MD322C8

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### Display Testing:

- ・ Display Reflection
- Luminance Response
- ・ Luminance Uniformity

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- Display Resolution
- ・ Display Noise
- Veiling Glare
- ・ Display Chromaticity
- Miscellaneous Tests

Summary: Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14.

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### CONCLUSION

- 1. 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. The SE Comparison Table compares the principal characteristics of two devices. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MD210C3 by NEC Display Solutions Ltd. (K142951)