← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K133708 # MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR (K133708) _Nec Display Solutions , Ltd. · LLZ · Feb 14, 2014 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K133708 ## Device Facts - **Applicant:** Nec Display Solutions , Ltd. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Feb 14, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The MD302C4 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. MD302C4 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 MD302C4 is a 29.8-inch color TFT LCD diagnostic monitor; provides 4-megapixel (2560x1600) resolution; displays digital images for diagnostic review by physicians in clinical environments (e.g., radiology departments). Input signals received via DVI-D, DisplayPort, or HDMI from NEC-approved display controllers. Device transforms digital input signals into high-resolution visual output; supports adjustable gamma grayscale and DICOM Part 14 calibration. Used by trained clinicians to interpret medical images; aids in diagnostic decision-making for CT, MRI, and PACS workflows. Benefits include high-resolution visualization of medical data; ensures diagnostic-grade display performance through strict interconnection requirements with IEC60601-1-1 certified equipment. ## Clinical Evidence Bench testing only. No clinical data provided. Evidence consists of performance comparisons, electrical/mechanical safety testing (ANSI/AAMI ES 60601-1), electromagnetic compatibility (EN60601-1-2), and DICOM conformance verification. ## Technological Characteristics 29.8" TFT Color LCD monitor; 2560x1600 resolution; 1000:1 contrast ratio; 16.7 million display colors. Connectivity via DVI-D, DisplayPort, and HDMI. Power: AC100-240V. Calibration: Software-based luminance calibration; supports DICOM Part 14 gamma curves. Safety standards: ANSI/AAMI ES 60601-1:2005, EN60601-1-2, DIN V 6868-57. Designed for exclusive use with NEC-approved display controllers. ## Regulatory 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 - MD242C2 Color LCD Monitor ([K132587](/device/K132587.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KB33708 Page 1 of 4 # 510(K) Summary of Safety and Effectiveness As required by 807.92 FEB 1 4 2014 #### DEVICE ESTABLISHMENT AND CONTACT PERSON l. Mr. Naohiko Shimazu Senior Manager NEC Display Solutions Ltd. 686-1 NISHIOI, OI-MACHI, ASHIGARAKAMI-GUN, KANAGAWA, 258-8533, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393 #### 2. COMPANY REISTRATION NUMBER 3003623028 #### 3. DATE SUMMARY PREPARED 09 October 2013 #### 4, DEVICE NAME | Trade Name: | MD302C4 29.8" Diagnostic Imaging LCD monitor | |----------------------|-------------------------------------------------------------------| | Model Name: | MD302C4 | | Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. | | Classification Name: | System, Image Processing, Radiological (CLASS II CFR
892.2050) | #### PREDICATE DEVICE 4. MD242C2 Color LCD Monitor by NEC Display Solutions Ltd. (K 132587) #### DEVICE DESCRIPTION 5. Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS. {1}------------------------------------------------ #### 6. DEVICE OF INTENDED USE The MD302C4 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. MD302C4 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 | MD242C2 | MD302C4 | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | | | | Panel Size and Type | 24.1" TFT Color LCD Monitor | 29.8" TFT Color LCD Monitor | | Pixel Pitch | 0.270 mm x 0.270mm | 0.251mm x 0.251mm | | Display Color | 1,073,741,824 | 16,777,216 | | Viewing Angles (°) | H:178, V:178 | H:178, V:178 | | Scanning Frequency
(H, V) | 31.5-93.8, 118.4kHz, 50-85 Hz | 31.5-98.7 kHz, 50-85 Hz | | Native Resolutions | 1920X1200 | 2560X1600 | | Brightness | 180 cd/m² calibrated,
350 cd/m² Max. | 180 cd/m² calibrated,
340 cd/m² Max. | | Contrast Ratio | 1000 : 1 (typical) | 1000 : 1 (typical) | | DOT Clock | 202.5 MHz (Max) (Analog)
162 MHz (Max) (Digital) | 269 MHz (Max) | | Input Signals | Three connectors: one DVI port,
one Display port, one HDMI port. | Three connectors: one DVI port,
one Display port, one HDMI
port. | | Input Terminals | DVI-D, Display port, HDMI port | DVI-D, Display port, HDMI port | | USB (option) / Standard | No | No | | Active Display Size (H x V) | Landscape: 518.4mmX324mm
Portrait: 324X518.4mm | Landscape: 641mmX401mm
Portrait: 401X641mm | | Viewable Image Size | 540 mm (diagonal) | 756 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 | | Power Consumption | 38.4W (Max) | 87W (Max) | | Power Save Mode | <2W | <2W | | Dimensions (W x H x D) | W:
Landscape: 556.8mm
Portrait: 362.4 mm
H:
Landscape: 378 - 528mm
Portrait: 572.4-625.2mm
D: 227.6 mm | W:
Landscape: 688mm
Portrait: 446.8 mm
H:
Landscape: 466.4 - 616.4mm
Portrait: 707.1-737.0mm
D: 301.6 mm | | NET Weight | 10.2 kg | 17 kg | | Intended of use | Displaying and viewing of digital images for diagnosis by trained physicians
This device can not use for a life support system.
This device must not be use in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment | Displaying and viewing of digital images for diagnosis by trained physicians
This device can not use for a life support system.
This device must not be use in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment | | Certifications & Standards | CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), 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 MD302C4 & MD242C2 {2}------------------------------------------------ v - 3 : {3}------------------------------------------------ K133708 Page 4 of 4 ### 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 MD242C2 by NEC Display Solutions Ltd. (K132587) {4}------------------------------------------------ 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Center - WO66-G609 Silver Spring, MD 20993-0002 February 14, 2014 NEC Display Solutions, Ltd. % Mr. Tony Hsu Safety Engineer Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec. 2 Wunhua 1st Road. Linkou Township NEW TAIPEI CITY 24457 TAIWAN Re: K133708 Trade/Device Name: MD302C4 29.8" Diagnostic Imaging LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 23, 2013 Received: December 23, 2013 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 {5}------------------------------------------------ Page 2-Mr. Hsu 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K133708 Device Name MD302C4 Indications for Use (Describe) The MD302C4 color display is 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 for in conjunction with NEC approved display controllers. MD302C4 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) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {7}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K133708](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K133708) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com