← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K042755 # MONOCHROME LCD MONITOR, RADIFORCE G51 (K042755) _Eizo Nanao Corporation · LLZ · Feb 10, 2005 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K042755 ## Device Facts - **Applicant:** Eizo Nanao Corporation - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Feb 10, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use RadiForce G51 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system. ## Device Story RadiForce G51 is a 21.3-inch TFT monochrome LCD monitor designed for medical imaging, including digital mammography. It receives digital video input via DVI-D interface from a medical workstation. The device displays high-resolution (2048 x 2560) monochrome images to radiologists or clinicians in clinical environments. It features a 700 cd/m² brightness and 600:1 contrast ratio. The monitor supports optional luminance calibration via an external photo-sensor and software. The output provides visual diagnostic information to assist healthcare providers in clinical decision-making and image interpretation. It serves as a replacement for CRT-based display systems, offering a thinner form factor and specific luminance performance for diagnostic radiology. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics 21.3-inch TFT monochrome LCD panel; 0.165 mm pixel pitch; 2048 x 2560 native resolution; 700 cd/m² brightness; 600:1 contrast ratio; DVI-D 24-pin input; RS232/Mini DIN serial ports for remote control/sensor; AC power 100-240V; Standards: EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, VCCI-A. ## 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 - Barco NV Barcoview Digital Mammography Display Model MDG 521M ([K033859](/device/K033859.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}------------------------------------------------ K042755 510(k) Summary as required by 807.92 - 1. Company Identification EIZO NANAO CORPORATION 153 Shimokashiwano cho, Matto shi, Ishikawa ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484 - 2. Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section - 3. Date of Submission October 4, 2004 - 4. Device Trade name RadiForce G51, 5 Megapixel Monochrome LCD Monitor - 5. Common/Usual Name: Image display system, medical image workstation, image monitor/display, and others - 6. Classification Number: Medical displays classified in Class II per 21 CFR 892.2050. - 7. Predicate Device Manufacturer: Barco NV Barcoview Device Name: Digital Mammography Display Model Name: MDG 521M 510(k) No.: K033859 - 8. Description of Device RadiForce G51 device is a digital image display. Clearance letter (510(k) No. K032026, dated on AUG 27, 2003) had been issued. The device is qualified for various medical image applications including digital mammography system. - 9. Intended Use RadiForce G51 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system. - 10. Substantial Equivalence to Predicate Device RadiForce G51 is substantially equivalent to MDG 521M. G51 employs the maximum resolution values same as that of MDG 521M. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1 and specification data for the use of mammography system monitor is included in Attachment 8. {1}------------------------------------------------ ## Appendix 1: Comparison Table with Predicate Device | Items | MDG 521 (Predicate Device) | RadiForce G51 | |--------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | 510(k) Number | K033859 | Not known | | Panel Size and Type | 21" CRT display | 21.3" TFT monochrome LCD
display | | Picture Tube/Pixel Pitch | Faceplate transmission: 32%
Phosphor: P45 (standard) or P104 | 0.165 mm x 0.165 mm | | Available Cabinet Colors | Black | Black | | Scanning Frequency
(H, V) | H: 160-200kHz
V: 48-150Hz | H: 103.9 kHz
V: 50.06 Hz | | Native Resolutions | 2048 x 2560 (portrait) | 2048 x 2560 (portrait)
2560 x 2048 (landscape) | | Brightness | 450 cd/m² | 700 cd/m² | | Contrast Ratio | 2000:1 | 600:1 | | DOT Clock | 500MHz pixel clock | 152MHz | | Input Signals | BNC | DVI Standard 1.0 | | Input Terminals | BNC | DVI-D 24 pin x 1 | | Serial Ports | 1 input, 1 output
9600 baud, RS232
SUB-D9 male/female
connector | D-Sub 9 pin (Remote Out),
Mini DIN 6 pin (Remote In),
Mini DIN 8 pin (Photo Sensor) | | Active Display Size
(H x V) | 300 x 400 mm / 304 x 380 mm | 337.9 x 422.4 mm | | Dimensions (W x H x D) | 558 x 400 x 561 mm | 388 x 572 x 83.5 mm | | Luminance Calibration | Software (Optional)
Photo-sensor (Optional) | Software (Optional)
Photo-sensor (Optional) | | Power | AC90-264V
50-60Hz | AC100V-120V/200V-240V,
50/60Hz, | | Certifications &
Standards | cUL950, CE, IEC601-1,
UL2601-1, cUL2601, UL1950,
DIN 6868-57 | TUV/GM, CE, CB, EN60601-1,
UL2601-1, CSA C22.2 No. 601-1,
FCC-A, Canadian ICES-003-A,
VCCI-A, CCC | *Since the software used in G51 is not changed, refer to the 510(k) Summary of K32026 for the information of calibration software. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Hiroaki Hashimoto Manager of Product Safety & EMC EIZO NANAO Corporation 153 Shimokashiwano, Matto Ishikawa 924-8566 JAPAN Re: K042755 FEB 1 0 2005 Trade/Device Name: RadiForce G51 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 29, 2004 Received: January 3, 2005 Dear Mr. Hashimoto: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your Section 510(ts) promantially equivalent (for the indications for use stated in above and have decemined the aboved icate devices marketed in interstate commerce prior to the enclosure) to regally maneled produced Device Amendments, or to devices that have been Way 26, 1770, the Chactified and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation was a proval application (PMA). You may, therefore, market the do not require approval of a prematics approvisions of the Act. The general controls provisions of the Act device, subject to the general one prove, 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 (Premarket If your device is classince (300 additional controls. Existing major regulations affecting your Apploval), It may oc subject to been aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA uevice can oc round in the cenents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Frease oc advisor mar PDT 5 tookies of the vice complies with other requirements of the Act or any FDA has made a decemination and your as the Federal agencies. You must comply with all the Federal statues and regulations administer of of east and listing (21 CFR Part 807); labeling Act s requirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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) I mis icuer will anow you to oogin maneeing your antial equivalence of your device to a legally premarket nothleation. The I DA mainly of bassamal sepproceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.97). I ou may onam only general missistance at its toll-free number (800) DVISIon of 311an Mandracturers, Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html Sincerely yours, Nancy C. brogdon 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: RadiForce G51 Indications For Use: 5 Megapixel Monochrome LCD Monitor, RadiForce G51 is intended to be used in various 5 Megapixel Monochrome HOD including digital mammography system for which the Kinds of medical mage appeacations specified by the manufacturer of the system. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Laymon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K042755](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K042755) **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