8MP COLOR LCD MONITOR, REDIFORCE RX840

K120451 · Eizo Nanao Corporation · LLZ · Aug 3, 2012 · Radiology

Device Facts

• Record ID: K120451
• Device Name: 8MP COLOR LCD MONITOR, REDIFORCE RX840
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: Aug 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Indications for Use

The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Device Story

RadiForce RX840-MG is an 8MP color LCD monitor designed for medical imaging, including digital mammography. It utilizes an IPS color panel with LED backlighting to display high-resolution images (4096 x 2160). The device functions as a replacement for traditional dual-head 5MP monochrome monitor setups. It incorporates factory-calibrated display modes stored in internal lookup tables to ensure DICOM GSDF compliance regardless of the connected workstation or display controller. The monitor includes integrated sensors (backlight, front, presence, and ambient light) for quality control. It is used in clinical environments by trained medical practitioners to review and analyze diagnostic images. The device is supported by RadiCS application software for quality control management. By providing a high-resolution, color-capable display, it enables clinicians to view complex medical imagery, facilitating accurate diagnostic decision-making.

Clinical Evidence

No clinical or animal testing was performed. Substantial equivalence was established through bench testing following AAPM TG18 guidelines. Tests included DICOM GSDF conformance, angular luminance dependency, luminance/chromaticity non-uniformity, reflection measurements, contrast ratio, MTF, noise power spectrum (NPS), pixel aperture ratio, temporal response, and luminance stability.

Technological Characteristics

8MP (4096 x 2160) TFT Color LCD (IPS) panel; LED backlight; 10-bit grayscale support; Digital Uniformity Equalizer (DUE); DVI-D and DisplayPort inputs; integrated sensors (Backlight, Front, Presence, Ambient Light); 100-240V AC power; 350W power consumption.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including digital mammography, for review and analysis.

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

• RadiForce GX530 (K112354)

Submission Summary (Full Text)

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K|2045|

Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a square shape with a checkered pattern on the left side and the word "EIZO" in bold letters on the right side. The logo is black and white and has a registered trademark symbol next to the letter O.

#### 3 2012 AUG

| | Name | Hiroaki Hashimoto |
|---------------------------------------------------------------------------------|------------|--------------------------|
| | Department | Medical System Standards |
| U.S. Food and Drug Administration<br>Center for Devices and Radiological Health | Telephone | [phone] |
| Document Mail Center – WO66-G609 | Fax | [phone] |
| 10903 New Hampshire Avenue<br>Silver Spring, MD 20993-0002 | E-Mail | [e-mail] |
| | Date | February 3rd, 2012 |

## Traditional 510(k) Summary (in accordance with 21 CFR 807.92)

# 1. Date of Summary

February 3rd, 2012

# 2. Company

EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan

### 3. Authorized Contact Person

Hiroaki Hashimoto

#### 4. Device Information

- Trade Name/Model: RadiForce RX840-MG .
- Common Name: 8MP Color LCD Monitor .
- Classification Name: System, Image Processing, Radiological .
- 21 CFR 892.2050, Product Code LLZ . Regulation Number:

## 5. Predicate Device

- . 5MP Monochrome LCD Monitor, RadiForce GX530 (K112354)

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#### 6. Device Description

The RadiForce RX840-MG is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 4.096 x 2.160 pixels (8MP), the RX840-MG is an alternate replacement for traditional dual head 5MP display installations.

Image /page/1/Picture/2 description: The image shows two different medical monitors. The monitor on the left is a RadiForce RX360-MG, and the two monitors on the right are 5MP monitors. All three monitors are displaying medical images. The monitors are all black and have a thin bezel.

RadiForce RX840-MG

5MP Monochrome Monitors

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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX840-MG based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840-MG.

#### 7. Intended Use

The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

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# 8. Comparison of Technological Characteristics

The comparison table below enumerates information derived from the product literature of the each device and different technological characteristics are discussed in it:

| Attributes | Eizo RadiForce<br>RX840-MG | Eizo RadiForce<br>GX530 | Explanation of<br>Differences |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen<br>technology | TFT Color<br>LCD Panel (IPS) | TFT Monochrome<br>LCD Panel (IPS) | Monochrome vs. Color<br>(w/o & w/ color filters).<br>See main text. |
| Viewing<br>angle (H, V) | H: 176°, V: 176° | H: 170°, V: 170° | Eizo uses the typical data<br>for very low contrast 10:1<br>given by the panel<br>manufacturers |
| Active screen<br>size | 817.1 x 430.9 mm<br>(408.05 x 430.9 mm x 2) | 337.9 x 422.4mm | The difference of 400<br>pixels in vertical<br>direction |
| Resolution | 8 MP (4,096 x 2,160)<br>(4MP: 2,048 x 2,160 x 2) | 5 MP (2,048 x 2,560) | direction is such a<br>degree that it can be<br>easily negated e.g. by a<br>small amount of<br>panning manipulation<br>or by changing the tool<br>bar setting of the<br>viewer software<br>(location, disappear<br>when the cursor isn't<br>on it etc.) |
| Aspect ratio | 17 : 9<br>(8.5 : 9 x 2) | 4 : 5 | |
| Pixel pitch | 0.1995 x 0.1995 mm | 0.165 x 0.165 mm | |
| Maximum<br>luminance | 700 cd/m² | 1,200 cd/m² | Smaller maximum<br>luminance value means<br>shorter period during<br>which calibrated<br>luminance can be<br>guaranteed: RX840-MG:<br>10K hours vs. GX530:<br>40K hours. |
| DICOM<br>calibrated<br>luminance | 500 cd/m² | 500 cd/m² | |
| Contrast ratio | 1000: 1 | 1200 : 1 | Eizo uses typical contrast<br>ratio data provided by<br>panel manufacturers. |
| Backlighting | LED | CCFL | See main text. |
| Grayscale<br>Tones | 10-bit:<br>1,024 from a palette of<br>4,096 tones<br>8-bit: 256 from a palette<br>of 4096 tones | 10-bit (DisplayPort):<br>1,024 from a palette of<br>16,369 tones<br>8-bit: 256 from a palette<br>of 16,369 tones | See main text. |
| Luminance<br>non-<br>uniformity<br>compensation | Digital Uniformity<br>Equalizer (DUE) | Digital Uniformity<br>Equalizer (DUE) | |
| Video Signal Input | | | |
| Input video<br>signals | DVI-D (Dual Link) x 2,<br>DisplayPort x 2 | DVI-D (Dual Link) x 1 ,<br>DisplayPort x 1 | |
| Scanning<br>Frequency<br>(H, V) | 31 - 140 kHz, 29.5 - 30.5<br>Hz (2048 x 2160, 1920 x<br>2160), 59 - 61 Hz,<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 29.5 - 30.5 Hz,<br>59 - 61 Hz | 31 - 135 kHz, 24 - 61 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 24.5 - 25.5 Hz,<br>49 - 51 Hz | |
| Dot Clock | DVI-D: 310 MHz,<br>DisplayPort: 290 MHz | 290 MHz | |
| Display<br>controller | Off the shelf | Off the shelf | |
| Power Related Specifications | | | |
| Power<br>Requirements | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | |
| Power<br>Consumption<br>/ Save Mode | 350 W / Less than 6 W | 130 W / Less than 2.5 W | The<br>proposed<br>device<br>consumes more<br>power<br>due to the larger panel<br>size. |
| Power<br>Management | DVI DMPM,<br>DisplayPort 1.1a | DVI DMPM,<br>DisplayPort 1.1a | |
| Miscellaneous Features/Specifications | | | |
| QC software | RadiCS | RadiCS | |
| Sensors | Backlight Sensor (BS),<br>Integrated Front Sensor<br>(IFS),<br>Presence Sensor (PS),<br>Ambient Light Sensor<br>(ALS) | Backlight Sensor (BS),<br>Integrated Front Sensor<br>(IFS),<br>Presence Sensor (PS),<br>Ambient Light Sensor<br>(ALS) | |
| USB Ports / | 1 upstream, | 1 upstream, | |
| Standard | 2 downstream / Rev. 2.0 | 2 downstream / Rev. 2.0 | |
| Dimensions<br>w/o stand<br>(W x H x D) | 896 x 527 x 157 mm | 388 x 496 x 99 mm | Different housing design<br>due to the different panel<br>size. |

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For the substantial equivalence determination, only the following differences of the technological characteristics need further evidences by performance testing:

- ' The RadiForce RX840-MG employs a color LCD panel module though the predicate device employs a monochrome LCD panel module.
- . The smaller number of gray tones available to calibration of the color display (e.g. to GSDF) than that of the monochrome display may affect calibration accuracy.
- -The RadiForce RX840-MG employs an LED backlight though the predicate device employs a CCFL backlight; advantage of the LED backlight is that it is mercury-free, consumes less power and deteriorates more slowly.

# 9. Performance Testing

The following bench tests were performed on the RadiForce RX840-MG 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 RX840-MG

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The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX840-MG.

#### 10. Conclusion

The 8MP Color LCD Monitor, RadiForce RX840-MG to be used in dual-head configuration has the same intended use as the predicate device but some different technological characteristics. Bench testing showed that the safety and effectiveness of the RadiForce RX840-MG was not affected by the differences of the technological characteristics. Therefore, the RadiForce RX840-MG was determined to be substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002

> 3 2012 AUG

Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation 153 Shimokashiwano HAKUSAN ISHIKAWA 924-8566 JAPAN

Re: K120451

Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX840-MG Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2012 Received: July 19, 2012

#### Dear Mr. 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 I o a may) ontrols 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 class II (Special Controls), it may be subject to such 11 Jour wortols. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r total of acreating 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 compy "Har an an an an and 809); medical device reporting (reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): _

8MP Color LCD Monitor, RadiForce RX840-MG Device Name:

Indications for Use:

The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Over-The-Counter Use X Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

sion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K1200451

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