5MP Monochrome LCD Monitor, RadiForce GX540

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 30, 2015 EIZO Corporation % Hiroaki Hashimoto Manager 153 Shimokashiwano Hakusan, 924-8566 JAPAN Re: K151883 Trade/Device Name: 5MP Monochrome LCD Monitor, RadiForce GX540 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 3, 2015 Received: July 9, 2015 Dear Hiroaki Hashimoto: 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. {1}------------------------------------------------ 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K151883 Device Name 5MP Monochrome LCD Monitor, RadiForce GX540 Indications for Use (Describe) This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications. Type of Use (Select one or both, as applicable) 2 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) 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. 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EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Janan U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Name Department Hiroaki Hashimoto Medical System Standards Telephone Fax E-Mail +81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com ## 510(k) Summary (in accordance with 21 CFR 807.92) #### 1. Company EIZO Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484 ### Contact Person 2. Hiroaki Hashimoto ### 3. Date of Summary July 3rd, 2015 ● ● #### 4. Device Information - Trade Name/Model: RadiForce GX540 ● - 5MP Monochrome LCD Monitor ● Common Name: - Classification Name: Display, Diagnostic Radiology - 21 CFR 892.2050, Product Code PGY Regulation Number: - 510(k) Number: K130336 (for digital mammography) ● #### 5. Predicate Device - Trade/Device Name: ● - 510(k) Number: ● Barco Mammo Tomosynthesis (MDMG-5221) K103792 {4}------------------------------------------------ #### 6. Device Description RadiForce GX540 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. There are two model variations, GX540-CL and GX540-CLAR (GX540 without any suffix does not exist). The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX540-CL is Anti-Glare (AG) treatment and that of the GX540-CLAR is Anti-Reflection (AR) coating. The suffix common to the both variations, " - CL", means that the tint of the backlight is Clear Base (vs. Blue Base, another popular tint slightly bluish). RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX540. #### 7. Intended Use This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications. {5}------------------------------------------------ ### Comparison of Technological Characteristics 8. The comparison table below enumerates information derived from the product brochure of the each device and other differences are discussed: | Attributes | EIZO RadiForce<br>GX540 | Barco MDMG-5221 | Explanation of<br>Differences | |----------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Display Performance/Specifications | | | | | Response<br>Time<br>(typical) | 25 ms (On/Off) | 15 ms (Tr + Tf) | EIZO uses typical data<br>provided by the panel<br>manufacturer.<br>See main text for further<br>explanation. | | Resolution or<br>Matrix Size | 5MP (2,048 x 2,560) | 5MP (2,048 x 2,560) | - | | Screen<br>Technology | TFT Monochrome<br>LCD Panel (IPS) | TFT (Monochrome)<br>AMLCD Dual Domain<br>IPS WideView | - | | Backlighting | LED | CCFL | See main text for further<br>explanation. | | Maximum<br>Luminance | 1,200 cd/m² | 2,100 cd/m² | The luminance ratio (max/min)<br>between 250 and 650 generally<br>recommended taking account<br>of the contrast sensitivity of<br>human eyes is available in the<br>proposed devices. EIZO does<br>not see merits of the extremely<br>high luminance offering<br>contrast beyond what the eyes<br>can see. | | DICOM<br>Calibrated<br>Luminance | 500 cd/m² | 1,000 cd/m² | - | | Viewing<br>Angle (H, V) | H: 176°, V: 176° | 176° | - | | Active<br>Screen Size | 337.9 mm x 422.4 mm | 337.9 mm x 422.4 mm | - | | Aspect Ratio | 4:5 | 4:5 | - | | Pixel Pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm | - | | Contrast<br>Ratio | 1200:1 | 950:1 | - | | Grayscale<br>Tones | 10-bit (DisplayPort): 1,024<br>from a palette of 16,369<br>tones<br>8-bit: 256 from a palette of<br>16,369 tones | Number of grayscales<br>(LUT in/LUT out):<br>1024 gray levels (10/12) | - | | Attributes | EIZO RadiForce<br>GX540 | Barco MDMG-5221 | Explanation of<br>Differences | | Non-<br>Uniformity<br>Compensation | Digital Uniformity<br>Equalizer (DUE) | Per Pixel Uniformity | The both features are intended to<br>improve uniformity of<br>brightness and color. | | Video Signal Input | | | | | Input Video<br>Signals | DVI-D (dual link) x 1,<br>DisplayPort x 1 | DVI, DisplayPort | - | | Scanning<br>Frequency<br>(H, V) | 31 - 135 kHz / 24 - 61 Hz<br>Frame synchronous<br>mode: 24.5 - 25.5 Hz, 49<br>- 51 Hz | 30-150 kHz; 15-80 Hz | - | | Dot Clock | 290 MHz | 280 MHz | - | | Power Related Specifications | | | | | Power<br>Requirements | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | 100 - 240 V | - | | Power<br>Consumption | 108 W / Less than 0.7 W | 125 W (nominal) | - | | Power<br>Management | DVI DMPM,<br>DisplayPort 1.1a | DVI-DMPM | - | | Miscellaneous Features/Specifications | | | - | | QC Software | RadiCS | MediCal QAWeb | - | | Sensors | Integrated Front Sensor<br>(IFS) | I-Guard | The both sensors/technologies<br>enable automatic grayscale<br>check and calibration by<br>measuring the luminance at the<br>screen surface. | | | Backlight Sensor (BS) | Backlight Output<br>Stabilization (BLOS)? | BS enables backlight<br>brightness stabilization by<br>measuring the backlight<br>brightness directly and the<br>feature is very common to<br>medical displays.<br>The implementation of BLOS<br>on the predicate device is not<br>certain though the feature is<br>mentioned in the overall<br>products brochure. | | | Ambient Light Sensor<br>(ALS) | Hemispherical Ambient<br>Light Sensor | - | | Attributes | EIZO RadiForce<br>GX540 | Barco MDMG-5221 | Explanation of<br>Differences | | | Presence Sensor (PS) | - | PS detects the absence of the<br>user as a trigger of the power<br>saving mode. | | USB Ports /<br>Standard | 1 upstream,<br>2 downstream / Rev. 2.0 | 1 upstream + 1 endpoint,<br>2 downstream / Rev. 2.0 | - | | Dimensions<br>w/o Stand<br>(W x H x D) | 388 x 496 x 99 mm | 392 x 484 x 123 mm | Different housing design due<br>to the different panel size. | {6}------------------------------------------------ {7}------------------------------------------------ For the substantial equivalence determination, only the difference of the response time needs further evidences by performance testing for the proposed additional usage, "multi-frame digital mammography" or "digital breast tomosynthesis". {8}------------------------------------------------ #### 9. Performance Testing # 9.1. Bench Testing The following bench tests were performed on the RadiForce GX540 following instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions: - Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline) - Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions - . Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline - Measurement of the chromaticity non-uniformity characteristics of the display screen . as specified in TG18 guideline - . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance - Measurement of display reflections including specular, diffuse and haze components ● - Measurement of small-spot contrast ratio - . Measurement of spatial resolution expressed as modulation transfer function (MTF) - . Measurement of noise expressed as noise power spectrum (NPS) - Measurement of pixel aperture ratio - Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline - . Measurement of temporal response - Performance data on luminance stability ● - The maximum number allowed for each type of pixel defects/faults agreed with the . manufacturer from which EIZO buys the LCD panels for RadiForce GX540 The test results showed that the display characteristics of the RadiForce GX540 meet the pre-defined criteria when criteria are set. The corresponding testing data of the predicate device, Barco Mammo Tomosynthesis (MDMG-5221), was not available because the device is from other manufacturer. # 9.2. Clinical Testing The goal of the clinical testing was to assess the image quality of tomosynthesis images on the proposed device compared to that on the predicate device. The results of the testing indicated that the proposed device is at least equivalent to the predicate device for viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images. {9}------------------------------------------------ ## 9.3. Animal Testing No animal testing was performed on the RadiForce GX540. #### Conclusion 10. The RadiForce GX540 was determined to be substantially equivalent to the predicate device due to the following reasons: - The stated intended use is substantially the same as that of the predicate device. - It was confirmed that the technological characteristics different from those of the . predicate device do not affect the safety and the effectiveness except one item, which was determined that it would not affect observer's performance based on the results of the clinical testing.