← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K032020 # 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW (K032020) _Iiyama Corporation · LLZ · Sep 2, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K032020 ## Device Facts - **Applicant:** Iiyama Corporation - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Sep 2, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X ray or MRI and others application for medical. This is the same intended use for the previously cleared for RadiForce G21, K024358. ## Device Story The MU5111BW is a 20.1-inch TFT monochrome LCD monitor designed for medical imaging. It receives digital or analog video signals from medical imaging systems (e.g., X-ray, MRI) and displays them for clinical diagnostic review. The device features a native resolution of 1600x1200 (landscape) or 1200x1600 (portrait), a typical brightness of 700 cd/m², and a 1000:1 contrast ratio. It includes an auto-adjustment function to optimize display parameters. The monitor is intended for use in clinical environments by healthcare professionals to assist in diagnostic decision-making. It connects to workstations via DVI-I and includes USB 2.0/1.0 ports for peripheral connectivity. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics 20.1-inch TFT monochrome LCD panel; 0.255mm pixel pitch; 170° viewing angle; 1600x1200/1200x1600 resolution; 700 cd/m² brightness; 1000:1 contrast ratio; DVI-I input; USB 2.0/1.0 ports; VESA DPMS power management; 100-230VAC power supply. ## 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 - 20.1" Monochrome LCD Monitor, RadiForce G21 ([K024358](/device/K024358.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}------------------------------------------------ ## - 2 2003 # 510(k) Summary as required by 807.92 1. Company Identification IIYAMA CORPORATION 710-1 Kitaowaribe, Nagano city, Nagano Pref. 381-0014, Japan TEL: +81-26-263-5114 FAX: +81-26-263-5124 2. Official Correspondent Kazuyoshi Tateiwa (Mr.) / Deputy Group Manager Visual-Media Control Division Technical Support Group Technical No. 2 Dept. #### 3. Date of Submission June 26, 2003 - 4. Device Trade name 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW #### 5. Common Name Monitor, display, workstation, and others #### 6. Classification Medical displays were classified in Class II per 21 CFR 890.2050. #### 7. Predicate Device | Manufacturer | : EIZO NANAO CORPORATION | | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | Device Name | : 20.1" Monochrome LCD Monitor | | | Model Name | : RadiForce G21 | | | 510(k) No. | : K024358 | | | Items | G21 | MU5111BW | | 510(k) Number | K024358 | | | Panel Size and Type | 51 cm (20.1") TFT monochrome LCD panel | 51cm(20.1") TFT monochrome LCD panel | | Pixel Pitch | 0.255 mm x 0.255 mm | 0.255mm x 0.255mm | | Available Cabinet Colors | Black | Black | | Display Colors | 1,531 grayscale tones | Maximum 256-level monochrome | | Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° | | Scanning Frequency (H, V) | Analog: 31.5 kHz – 130kHz,
50 kHz – 85kHz
Digital: 31.5 kHz - 75kHz,
60 Hz (VGA Text: 70Hz) | fH: 24.0-80.0kHz,
fv : 56-85Hz | | Native Resolution | 1600 x 1200 (landscape),
1200 x 1600 (portrait) | 1600 x1200 (Landscape)
1200 x1600 (Portrait) | | Brightness | 700 cd/m² | 700cd/m²(Typical) | | Contrast Ratio | 1000: 1 (Typical) | 1000: 1 (Typical) | | DOT Clock | Analog: 240MHz
Digital: 162MHz | Digital: 162MHz | | Response Time | 30 ms (typical) | 25ms | | Input Signals | RGB Analog,
DVI Standard 1.0 | Analog: 0.7Vp-p(Standard), 75Ω Positive
Digital: DVI Standard Rev.1.0 | | Input Terminals | DVI-D 29 pin,
BNC | DVI-I 29pin | | USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1upstream, 4downstream, Rev. 2.0/1.0 | | Serial Ports | D-Sub 9 pin (Remote Out),
Min DIN 6 pin (Remote In)
Mini DIN 8 pin (Photo Sensor) | Not provided. | | Active Display Size (H, V) | 408 mm x 306 mm
(16.1" x 12.0") | 408 mm x 306 mm
(16.1" x 12.0") | | Viewable Image Size | 510 mm (20.1") (diagonal) | 510mm (20.1") (diagonal) | | Power Management | VESA DPMS
DVI-DMPM | VESA DPMS | | Power Consumption | 55 watts (typical) | 70 watts maximum | | Power Save Mode | Less than 8 watts | Less than 5 watts | | Dimensions (W x H x D) | With Stand:
449 mm x 456 – 528 mm x 209 mm
(17.7" x 18.0" x 20.8" x 8.2")
Without Stand:
449 mm x 347 mm x 86.5 mm
(17.7" x 13.7" x 3.4") | 466 x 424 – 534 x 241 mm / 18.3×16.7-21×9.5" | | Luminance Calibration | Software (Standard)
Photo-sensor (Standard)
Protection panel (Standard) | No calibration software used.
Auto adjustment function provided. | | Power | 10V-120V/200V-240V, 50/60Hz,
0.65A-0.4A, 0.35A-0.2A | 100-230VAC, 50/60Hz 0.7-0.35A | | NET Weight | With Stand: 10.5 kg (23.1 lbs),
Without Stand: 7.3 kg (16.1lbs) | 10kg / 22lbs | | Certification & Standards | TUV/GM, c-TUV, CE, CB, EN60601-1,
UL2601-1, CSA C22.2 No. 601-1, FCC-A, | Under applications for
UL / C-UL, TUV-GS, CB, | ### 8. Description of Device 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is a display for medical use. ### 9. Intended Use 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X ray or MRI and others application for medical. This is the same intended use for the previously cleared for RadiForce G21, K024358. #### 10. Compliance standards Please refer to Appendix 1. {1}------------------------------------------------ Appendix 1: Comparison Table with Predicate Device - Comparing to a predicate device, EIZO NANAO RadiForce 21, Iiyama's MU5111BW has only a ● few differences. MU5111BW does not have serial ports, and automatic adjustment function provided. However, the basic structure of both models is the same in terms of LCD display with stand and its functions. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a logo with a stylized bird inside a circle. The bird is composed of three curved lines that suggest wings and a body. The circle surrounding the bird is made up of small, indistinct shapes, possibly letters or symbols. The logo is black and white and appears to be a simple, graphic design. ood and Drug Administration 0 Corporate Boulevard Rockville MD 20850 SEP - 2 2003 Mr. Kazuyoshi Tateiwa Deputy Group Manager Ilyama Corporation 710-1 Kitaowaribe, Nagano City, Nagano Pref., 381-0014 JAPAN Re: K032020 Trade/Device Name: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: June 27, 2003 Received: July 10, 2003 Dear Mr. Tateiwa: 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); 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely vours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICAITIONS FOR USE STATEMENT KO3 2020 510(k) Number (If known): Device Name: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW Indications for Use: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X-ray or MRI, etc. (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IP NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Segerson and Ra 510(k) Numb Prescription Use (Per 21CFR 801.109) OR Over The Counter Use_ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K032020](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K032020) **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