8MP COLOR LCD MONITOR, RADIFORCE RX850

K140702 · Eizo Corporation · PGY · Apr 4, 2014 · Radiology

Device Facts

• Record ID: K140702
• Device Name: 8MP COLOR LCD MONITOR, RADIFORCE RX850
• Applicant: Eizo Corporation
• Product Code: PGY · Radiology
• Decision Date: Apr 4, 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 including those of digital mammography for review and analysis by trained medical practitioners.

Device Story

RadiForce RX850 is an 8MP color LCD monitor utilizing IPS technology for medical image display, including digital mammography. It serves as an alternative to dual-head 5MP display setups. The device accepts video signals via DVI-D or DisplayPort and features integrated sensors (backlight, front, presence, ambient light) for quality control. It is operated by trained medical practitioners in clinical environments. The monitor uses internal lookup tables to ensure DICOM GSDF compliance regardless of the display controller. RadiCS software, installed on the workstation, provides quality control, quantitative testing, and visual testing as an accessory. The high-resolution display allows practitioners to review and analyze diagnostic images, supporting clinical decision-making through accurate, calibrated visualization of medical data.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Performance verified against AAPM TG18 guidelines, including DICOM GSDF conformance, luminance/chromaticity uniformity, MTF, NPS, temporal response, and pixel defect analysis.

Technological Characteristics

IPS TFT Color LCD; 8MP (4096 x 2160) resolution; LED backlighting; 17:9 aspect ratio; 850 cd/m² max luminance; 1450:1 contrast ratio. Connectivity: DVI-D (dual link) x 2, DisplayPort x 2, USB 2.0. Integrated sensors: backlight, front, presence, ambient light. Software: RadiCS for QC. Digital Uniformity Equalizer for luminance compensation.

Indications for Use

Indicated for trained medical practitioners to display and view digital medical 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 RX840-MG (K120451)

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 square shape with a checkered pattern on the left side and the word "EIZO" in bold, sans-serif font on the right side. There is a registered trademark symbol next to the "O" in "EIZO".

K140702
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# APR 0 4 2014

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 Standards

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 March 18th, 2014

#### 4. Device Information

- Trade Name/Model: · RadiForce RX850 �
- Common Name: 8MP Color LCD Monitor ●
- Classification Name: Display, Diagnostic Radiology .
- Product Code: PGY ●
- Regulation Number: 21 CFR 892.2050 .

#### 5. Predicate Device

- 8MP Color LCD Monitor, RadiForce RX840-MG (K120451) .

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### 6. Device Description

RadiForce RX850 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 RX850 is an alternate replacement for traditional dual head 5MP display installations.

Image /page/1/Picture/2 description: The image shows a computer monitor displaying two brain scans. The scans appear to be axial views, showing the brain from above. The scans are similar in appearance, with areas of varying brightness indicating different tissue densities or activity levels. The monitor is a standard desktop model with a stand.

RadiForce RX850

Image /page/1/Picture/4 description: The image shows two computer monitors displaying similar images of a brain scan. The scans appear to be cross-sectional views, with the brain's structure clearly visible. The monitors are black and have a standard desktop design with a base for support. The scans are likely being used for medical analysis or research purposes.

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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX850 based on the OC 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 RX850.

### 7. Intended Use

This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

### 8. Comparison of Technological Characteristics

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

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| Attributes | RadiForce RX850 | RadiForce RX840-MG | Explanation of<br>Differences |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen<br>technology | IPS TFT Color LCD | IPS TFT Color LCD | |
| Viewing<br>angle (H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Eizo uses typical data for<br>very low contrast<br>provided by the panel<br>manufacturers. |
| Resolution | 8MP (4,096 x 2,160) | 8MP (4,096 x 2,160) | |
| Aspect ratio | 17 : 9 | 17 : 9 | |
| Active<br>screen size | 697.9 mm x 368.0 mm | 817.1 mm x 430.9 mm | The smaller pixel pitch or<br>pixel size means higher |
| Pixel pitch | 0.1704 mm x 0.1704 mm | 0.1995 x 0.1995 mm | density usually resulting<br>in higher quality of<br>displayed images. If one<br>cares about the smaller<br>pixel size, the perceived<br>pixel size similar to that<br>of the predicate device<br>can be realized easily by<br>adjusting the viewing<br>distance. |
| Maximum<br>luminance | 850 cd/m² | 700 cd/m² | |
| DICOM<br>calibrated<br>luminance | 500 cd/m² | 500 cd/m² | |
| Contrast<br>ratio | 1450 : 1 | 1000 : 1 | Eizo uses typical contrast<br>ratio data provided by<br>panel manufacturers. |
| Backlighting | LED | LED | |
| Display<br>Colors | From a palette of 68 billion<br>colors:<br>- 10-bit input (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit input: 16.77 million<br>colors | From a palette of 68 billion<br>colors:<br>- 10-bit input (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit input: 16.77 million<br>colors | |
| Luminance<br>non-<br>uniformity<br>compensation | Digital Uniformity<br>Equalizer | Digital Uniformity<br>Equalizer | |
| Video Signal Input | | | |
| Input video signals | DVI-D (dual link) x 2, DisplayPort x 2<br>(two inputs are required) | DVI-D (dual link) x 2, DisplayPort x 2 | |
| Scanning Frequency (H, V) | 31 - 140 kHz / 59 - 61 Hz (VGA Text: 69 - 71 Hz)<br>Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 140 kHz / 29.5 - 30.5 Hz only for 2,048 x 2,160 and 1,920 x 2,160, 59 - 61 Hz for other matrix sizes<br>(VGA Text: 69-71 Hz)<br>Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz | |
| Power Related Specifications | | | |
| Power Requirements | AC 100 - 120 V, 200 - 240 V: 50 / 60 Hz | AC 100 - 120 V, 200 - 240 V: 50 / 60 Hz | |
| Power Consumption / Save Mode | 227 W / Less than 6 W | 350 W / Less than 6 W | |
| Power Management | DVI DMPM, DisplayPort 1.1a | The proposed device consumes less power than the predicate device. | |
| Miscellaneous Features/Specifications | | | |
| QC software | RadiCS | RadiCS | |
| Sensors | Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor | Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor | |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 2.0 | 1 upstream, 2 downstream / Rev. 2.0 | |
| Dimensions w/o stand (W x H x D) | 747 x 430 x 130 mm | 896 x 527 x 157 mm | |

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX850.

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#### 9. Performance Testing

The bench tests below were performed on the RadiForce RX850 following the 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

The test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce RX840-MG except 2 items, each of which was determined that it would not affect observer's performance.

Besides, the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX850.

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K140702
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## 10. Conclusion

The RadiForce RX850 was determined to be substantially equivalent to the predicate device due to the following reasons:

- The stated intended use is completely 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 or the effectiveness.
- The bench tests demonstrated that the display characteristics are equivalent to those of . the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three angled lines that resemble an abstract representation of a human figure or a bird in flight.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-GB09 Silver Spring, MD 20993-0002

April 4, 2014

EIZO Corporation % Mr. Hiroaki Hashimoto 153 Shimokashiwano. Hakusan ISHIKAWA 924-8566 JAPAN

Re: K140702

Trade/Device Name: 8MP Color LCD Monitor, RadilForce RX850 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: PGY Dated: March 18, 2014 Received: March 20, 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, 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 11 (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 clectronic 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.fda.gov/MedicalDevices/ResourcesforYou/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/MedicalDevices/Safctv/ReportaProblem/dcfault.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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K140702

#### Device Name

8MP Color LCD Monitor, RadiForce RX850

#### Indications for Use (Describe)

This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Type of Use (Select one or both, as applicable)

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)

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