6MP COLOR LCD MONITOR, RADIFORCE RX650

K134002 · Eizo Corporation · LLZ · Jan 31, 2014 · Radiology

Device Facts

• Record ID: K134002
• Device Name: 6MP COLOR LCD MONITOR, RADIFORCE RX650
• Applicant: Eizo Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Story

RadiForce RX650 is a 6MP color LCD monitor (IPS technology) designed for medical image review and analysis. It accepts video signals via DVI-D or DisplayPort from medical imaging workstations. The device features factory-calibrated display modes, including DICOM GSDF compliance, stored in internal lookup tables. It includes integrated sensors (backlight, front, presence, ambient light) for quality control. RadiCS software, installed on the workstation, manages quality control, performing quantitative and visual tests. The monitor is used by trained medical practitioners in clinical environments to view diagnostic images. By providing high-resolution, calibrated visual output, it assists clinicians in reviewing medical scans, excluding mammography.

Clinical Evidence

Bench testing only. Testing included verification of conformance to DICOM GSDF (AAPM TG18 guidelines), measurement of luminance and chromaticity non-uniformity, chromaticity at various luminance levels, and visual artifact checks. No clinical or animal data were provided.

Technological Characteristics

TFT Color LCD panel (IPS) with LED backlighting. Resolution: 6MP (3,280 x 2,048). Pixel pitch: 0.197 mm. Max luminance: 800 cd/m². Contrast ratio: 1000:1. Connectivity: DVI-D (dual link) x 2, DisplayPort x 2. Integrated sensors: backlight, front, presence, ambient light. Software: RadiCS for quality control. DICOM GSDF compliant via internal lookup tables.

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images for review and analysis. Not indicated for mammography diagnosis.

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 RX340 (K113562)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized diamond shape on the left and the word "EIZO" on the right. The diamond shape is made up of a grid of squares, some of which are filled in with black. The word "EIZO" is written in a bold, sans-serif font. There is a registered trademark symbol next to the "O" in "EIZO".

K134002
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EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan

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 Standard

JAN 3 1 2014

Telephone Fax E-Mail

[phone] [phone] [e-mail]

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

## 1. Company

EIZO Corporation 153 Shimokashiwano. Hakusan Ishikawa 924-8566 Japan Tel: [phone] Fax: [phone]

- 2. Contact Person
Hiroaki Hashimoto

## 3. Date of Summary December 20th, 2013

4. Device Information

- Trade Name/Model: RadiForce RX650 .
- Common Name: 6MP Color LCD Monitor .
- Classification Name: System. Image Processing. Radiological ●
- 21 CFR 892.2050. Product Code LLZ Regulation Number: .

## 5. Predicate Device

- 3MP Color LCD Monitor, RadiForce RX340 (K113562) .

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# 6. Device Description

RadiForce RX650 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 3,280 x 2,048 pixels (6MP), the RX650 is an optimum replacement for traditional dual head 3MP display installations.

Image /page/1/Picture/2 description: The image shows a RadiForce RX650 monitor displaying medical images. The screen is divided into two sections, each displaying a different medical scan. The left side is labeled "3MP", the right side is labeled "3MP", and the top is labeled "6MP", indicating the resolution or image size of each section.

RadiForce RX650

Image /page/1/Picture/4 description: The image shows two computer monitors displaying medical imaging data. Each monitor shows a series of scans, likely from a CT or MRI, displaying anatomical structures. The scans appear to focus on blood vessels and organs, possibly related to the renal system. The monitors are identical, suggesting a side-by-side comparison or a duplicated display for medical analysis.

3MP Color Displays

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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX650 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset. RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX650.

#### 7. Intended Use

This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

#### 8. Comparison of Technological Characteristics

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

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| Attributes | Eizo RadiForce<br>RX650 | Eizo RadiForce<br>RX340 | Explanation of<br>Differences |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen<br>technology | TFT Color LCD Panel<br>(IPS) | TFT Color LCD Panel<br>(IPS) | |
| Viewing<br>angle (H. V) | H: 176°, V: 176° | H: 170°, V: 170° | Eizo uses typical data for<br>very low contrast<br>provided by the panel<br>manufacturers |
| Active screen<br>size | 645.5 mm x 403.0 mm | 323.7 mm x 431.6 mm | |
| Resolution | 6MP (3,280 x 2,048) | 3MP (1,536 x 2,048) | |
| Aspect ratio | 16:10 | 3 : 4 | |
| Pixel pitch | 0.197 mm x 0.197 mm | 0.21075 mm x 0.21075<br>mm | The smaller pixel pitch<br>or pixel size means<br>higher density usually<br>resulting in higher<br>quality of displayed<br>images. If one cares<br>about the smaller pixel<br>size, the perceived<br>pixel size similar to<br>that of the predicate<br>device can be realized<br>easily by adjusting the<br>viewing distance. |
| Maximum<br>luminance | 800 cd/m² | 1,000 cd/m² | Though the smaller<br>maximum luminance<br>value usually results in<br>shorter period during<br>which the calibrated<br>luminance can be<br>guaranteed, the<br>guaranteed operating<br>periods of the both<br>devices are the same. |
| DICOM<br>calibrated<br>luminance | 400 cd/m² | 400 cd/m² | |
| Contrast ratio | 1000 : 1 | 1400 : 1 | Eizo uses typical contrast<br>ratio data provided by<br>panel manufacturers. |
| Backlighting | LED | LED | |
| Display<br>Colors | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit colors: 16.77<br>million colors | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit colors: 16.77<br>million colors | |
| Luminance<br>non-<br>uniformity<br>compensation | Digital Uniformity<br>Equalizer | Digital Uniformity<br>Equalizer | |
| Video Signal Input | | | |
| Input video<br>signals | DVI-D (dual link) x 2.<br>DisplayPort x 2<br>(two inputs are required) | DVI-D (dual link) x 1,<br>DisplayPort x 1 | |
| Scanning<br>Frequency<br>(H. V) | 31 - 129 kHz / 29 - 61 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 29.5 - 30.5 Hz. 59<br>- 61 Hz | 31 - 127 kHz. 29 - 61 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 29.5 - 30.5 Hz.<br>59 - 61 Hz | |
| 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 | 225 W / Less than 6 W | 125 W / Less than 3 W | The proposed device<br>consumes more 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,<br>Integrated Front Sensor,<br>Presence Sensor,<br>Ambient Light Sensor | Backlight Sensor,<br>Integrated Front Sensor,<br>Presence Sensor,<br>Ambient Light Sensor | |
| USB Ports /<br>Standard | 1 upstream,<br>2 downstream / Rev. 2.0 | 1 upstream,<br>2 downstream / Rev. 2.0 | |
| Dimensions<br>w/o stand<br>(W x H x D) | 692 x 466 x 109 mm | 376 x 505 x 98 mm | Different housing design<br>due to the different panel<br>size. |

.

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX650.

.

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K134002
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## 9. Performance Testing

The following bench tests were performed on the RadilForce RX650.

- 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 luminance non-uniformity characteristics of the display screen as . specified in the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% . of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket · Notification (510(k)) Submissions
- Visual check of presence or absence of miscellaneous artifacts on the display screen as . specified in the TG18 guideline
- The maximum number allowed for each type of pixel defects/faults .

The test results showed that the RadiForce RX650 has display characteristics equivalent to those of the predicate device, RadiForce RX340.

Besides, the display characteristics of the RadiForce RX650 meet the pre-delined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX650.

## 10.Conclusion

The RadiForce RX650 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 differences from those of the . predicate device do not affect the safety and the effectiveness.
- The bench tests demonstrated that the display characteristics are equivalent to those of . the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the graphic. The text and the graphic are both in black, set against a white background.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

January 31, 2014

EIZO Corporation % Mr. Hiroaki Hashimoto Manager 153 Shimokashiwano, Hakusan Ishikawa 924-8566 JAPAN

Re: K134002

Trade/Device Name: 6MP Color LCD Monitor, RadiForce RX650 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 31, 2013 · Received: January 7, 2014

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. Drue, 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. Iisting 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.

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Page 2-Mr. Hashimoto

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 [phone] or [phone] or at its Internet address

http://www.lda.gov/Medicall.cevices/Resourcesfor You/Industrv/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/McdicalDevices/SafetyReportaProblem/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/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

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# Indications for Use

| 510(k) Number (if known): | K134002 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | 6MP Color LCD Monitor, RadiForce RX650 |
| Indications for Use: | This product is intended to be used in displaying and viewing<br>digital images for review and analysis by trained medical<br>practitioners. It does not support the display of mammography<br>images for diagnosis. |

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

\$(m_{i})\$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> K134002 510(k)

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