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 Description

The RadiForce RX440 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2,560 x 1,600 pixels (4MP) with a pixel pitch of 0.2505 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. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX440" such as "RX440-AR", a model with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX440 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 RX440.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Eizo RadiForce RX440 monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance for RadiForce RX440
Conformance to DICOM GSDF (as specified in AAPM TG18 guideline)	Verification performed. No behaviors inconsistent with expected performance.
Luminance non-uniformity characteristics (as specified in TG18 guideline)	Measurement performed. No behaviors inconsistent with expected performance.
Chromaticity non-uniformity characteristics (as specified in TG18 guideline)	Measurement performed. No behaviors inconsistent with expected performance.
Chromaticity at center of display screen at 5%, 50%, and 95% of maximum luminance (as specified in FDA Guidance for Display Accessories for Full-Field Digital Mammography Systems)	Measurement performed. No behaviors inconsistent with expected performance.
Presence or absence of miscellaneous artifacts (as specified in TG18 guideline)	Visual check performed. No behaviors inconsistent with expected performance.
Maximum allowed pixel defects/faults	The maximum number agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce RX440. No mention of exceeding this.

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing performed on the RadiForce RX440. It does not specify a "test set" in terms of patient data or images. The testing was conducted on the device itself.

Sample Size for Test Set: Implicitly, the physical device(s) of the RadiForce RX440 model. Not specified as a quantity, but suggests testing was performed on at least one unit.
Data Provenance: The testing was performed by Eizo Nanao Corporation (Japan) on their own manufactured device. This is a prospective evaluation of the manufactured device's physical characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is not applicable to the described performance testing. The "ground truth" for these tests are objective technical specifications and measurement standards (e.g., DICOM GSDF, TG18 guideline specifications, FDA guidance). Expert consensus is not relevant for verifying these physical and performance aspects of a display monitor.

4. Adjudication Method for the Test Set

This is not applicable as there was no 'test set' of expert-reviewed data. The performance was assessed against objective technical standards and guidelines.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is outside the scope of testing a medical display monitor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone (algorithm-only) performance test was not done. This device is a display monitor, not an algorithm. Its performance is evaluated independently of human interpretation of displayed images, but it relies on a human user for its intended purpose.

7. The Type of Ground Truth Used

The ground truth used for these tests was objective technical specifications and industry standards/guidelines. These include:

DICOM GSDF (Grayscale Standard Display Function)
AAPM Task Group 18 (TG18 guideline) for Assessment of Display Performance for Medical Imaging Systems
FDA Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
Manufacturer's internal specifications for pixel defects/faults.

8. The Sample Size for the Training Set

This is not applicable. The RadiForce RX440 is a display monitor, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a display monitor.

Summary

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R 130070

Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a stylized square made up of smaller squares on the left and the word "EIZO" in block letters on the right. There is a registered trademark symbol next to the "O" in "EIZO".

Eizo Nanao 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

+81 (76) 274-2468

+81 (76) 274-2484

hiro@nanao.co.jp

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

1. Company

Eizo Nanao Corporation 153 Shimokashiwano. Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484

2. Contact Person

Hiroaki Hashimoto

3. Date of Summary

December 25th, 2012

4. Device Information

Trade Name/Model: RadiForce RX440 .
4MP Color LCD Monitor . Common Name:
. Classification Name: System, Image Processing, Radiological
- Regulation Number: 21 CFR 892.2050, Product Code LLZ

5. Predicate Device

4MP Color LCD Monitor, RadiForce RX430 (K112466) .

FEB 0 8 2013

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6. Device Description

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.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX440" such as "RX440-AR", a model with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX440 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 RX440.

7. Intended Use

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 RX440	Eizo RadiForce RX430	Explanation of Differences
Display Performance/Specifications
Screen technology	TFT Color LCD Panel (IPS)	TFT Color LCD Panel (IPS)	-
Viewing angle (H, V)	H: 176°, V: 176° @CR=10	H: 170°, V: 170° @CR=50	Eizo uses typical data for very low contrast provided by the panel manufacturers
Active screen size	641.28 mm x 400.8 mm	641.28 mm x 400.8 mm	-
Resolution	4MP (2,560 x 1,600)	4MP (2,560 x 1,600)	-
Aspect ratio	16:10	16:10	-
Pixel pitch	0.2505 mm x 0.2505 mm	0.2505 mm x 0.2505 mm	-
Maximum luminance	750 cd/m²	1,000 cd/m²	Though smaller maximum luminance

DICOMcalibratedluminance	400 cd/m²	400 cd/m²	value usually meansshorter warranty period ofthe calibrated luminance,the warranty period of theproposed device is longerthan that of the predicatedevice due to the LEDbacklight deterioratingmore slowly than theCCFL backlight.
Contrast ratio	1100:1	1100:1	Eizo uses typical contrastratio data provided bypanel manufacturers.
Backlighting	LED	CCFL	See main text below.
DisplayColors	10-bit colors1.07 Billion (maximum)colors8-bit colors:16.77 million from apalette of 68 billioncolors	10-bit colors1.07 Billion (maximum)colors8-bit colors:16.77 million from apalette of 68 billioncolors
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer
		Video Signal Input
Input videosignals	DVI-D (dual link) x 1,DVI-D (single link) x 1,DisplayPort x 1	DVI-D (dual link) x 1 ,DisplayPort x 1
ScanningFrequency(H, V)	31 -- 159 kHz, 29 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 59 - 61 Hz, 29.5 -30.5 Hz	31 - 100 kHz, 29.5 - 61Hz (VGA Text: 69 - 71Hz)Frame synchronousmode: 59 - 61 Hz, 29.5 -30.5 Hz	Wider frequency rangesare supported by theproposed device.
Dot Clock	280 MHz	290 MHz
Power Related Specifications
PowerRequirements	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	AC 100 - 120 V.200 - 240 V: 50 / 60 Hz
PowerConsumption/ Save Mode	167 W / Less than 0.7 W	200 W / Less than 1 W	The proposed deviceconsumes less power thanthe predicate device.
PowerManagement	DVI DMPM,DisplayPort 1.1a	DVI DMPM,DisplayPort 1.1a	-
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	-
Dimensionsw/o stand(W x H x D)	720 x 498 x 119 mm	720 x 498 x 119 mm	-

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・

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For the substantial equivalence determination, only the difference of the backlights needs further evidences by performance testing.

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9. Performance Testing

The following bench tests were performed on the RadiForce RX440:

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 agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce RX440

None of the tests revealed behaviors inconsistent with the expected performance.

No animal or clinical testing was performed on the RadiForce RX440.

10. Conclusion

The 4MP Color LCD Monitor, RadiForce RX440 is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the proposed device are the same as those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 8, 2013

Eizo Nanao Corporation c/o Hiroaki Hashimoto, Manager Medical Systems Standards 153 Shimokashiwano Hakusan JAPAN 924-8566

Re: K130070

Trade/Device Name: RadiForce RX440 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 9, 2013 Received: January 18, 2013

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.

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

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Page 2 – Hiroaki Hashimoto

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Diagnostics and Radiological Health at (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sean M. Boyd -S 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 Form

510(k) Number (if known):

4MP Color LCD Monitor, RadiForce RX440 Device Name:

Indications for Use:

X Over-The-Counter Use 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 Diagnostics and Radiological Health (OIR) Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) K130070

Page 1 of 1

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).