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

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.

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.

AI/ML Overview

The provided text describes the EIZO RadiForce RX650, a 6MP Color LCD Monitor intended for displaying and viewing digital medical images (excluding mammography). The document outlines the device's technical specifications, its comparison to a predicate device (RadiForce RX340), and the performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "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-defined criteria when criteria are set."

While the specific numerical acceptance criteria values are not explicitly stated in a table alongside measured performance in this document, the types of tests and the standards they conform to serve as the acceptance criteria. The reported performance is that the device meets these criteria and is equivalent to the predicate device.

Acceptance Criteria (Test Type / Standard)	Reported Device Performance
Conformance to DICOM GSDF as specified in AAPM Task Group 18 (TG18 guideline)	RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria.
Measurement of luminance non-uniformity characteristics (TG18 guideline)	RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria.
Measurement of chromaticity non-uniformity characteristics (TG18 guideline)	RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria.
Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance (FDA Guidance for Full-Field Digital Mammography Systems)	RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. (Note: The device does not support mammography, but this guidance was used for chromaticity measurements.)
Visual check of presence or absence of miscellaneous artifacts on the display screen (TG18 guideline)	RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria.
Maximum number allowed for each type of pixel defects/faults	RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria.

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

The document does not specify the sample size for the test set. The tests were "bench tests" performed on the RadiForce RX650, which implies laboratory testing of the device itself rather than a study involving patient data. Therefore, the data provenance is the device itself, likely from the manufacturer's testing facilities (EIZO Corporation, Japan). The study is a prospective testing of the device.

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

This information is not applicable and not provided. The testing relates to the technical display characteristics of the monitor, not to the interpretation of medical images by human experts. The "ground truth" here is objective physical measurements and adherence to technical standards (like DICOM GSDF, TG18 guidelines).

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in studies where human readers interpret data that needs to be assessed against a consensus ground truth. Here, the tests are objective measurements of the monitor's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a display monitor, not an AI-powered diagnostic tool. The document states, "No animal or clinical testing was performed on the RadiForce RX650."

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

Not applicable in the context of an AI algorithm as this device is a display monitor. However, the performance tests described are "standalone" in the sense that they evaluate the device itself (the monitor and its associated software like RadiCS) based on objective measurements and compliance with technical standards, without human interpretation of clinical outcomes.

7. The Type of Ground Truth Used:

The ground truth used for these technical performance tests consists of:

Established Technical Standards: DICOM GSDF (Digital Imaging and Communications in Medicine Grayscale Standard Display Function) and AAPM (American Association of Physicists in Medicine) Task Group 18 (TG18) guidelines.
FDA Guidance: Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems (used for chromaticity measurements, despite the device not being for mammography).
Manufacturer Specifications/Internal Criteria: "pre-defined criteria when criteria are set" for aspects like pixel defects/faults.

8. The Sample Size for the Training Set:

This is not applicable and not provided. This device is a hardware display monitor; it does not involve machine learning algorithms that require a "training set" of data.

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

This is not applicable as there is no training set for this device.

Summary

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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
Page 1 of 5

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

+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

1. Contact Person
  Hiroaki Hashimoto

3. Date of Summary December 20th, 2013

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

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.

7. Intended Use

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 RadiForceRX650	Eizo RadiForceRX340	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	TFT Color LCD Panel(IPS)	TFT Color LCD Panel(IPS)
Viewingangle (H. V)	H: 176°, V: 176°	H: 170°, V: 170°	Eizo uses typical data forvery low contrastprovided by the panelmanufacturers
Active screensize	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 0.21075mm	The smaller pixel pitchor pixel size meanshigher density usuallyresulting in higherquality of displayedimages. If one caresabout the smaller pixelsize, the perceivedpixel size similar tothat of the predicatedevice can be realizedeasily by adjusting theviewing distance.
Maximumluminance	800 cd/m²	1,000 cd/m²	Though the smallermaximum luminancevalue usually results inshorter period duringwhich the calibratedluminance can beguaranteed, theguaranteed operatingperiods of the bothdevices are the same.
DICOMcalibratedluminance	400 cd/m²	400 cd/m²
Contrast ratio	1000 : 1	1400 : 1	Eizo uses typical contrastratio data provided bypanel manufacturers.
Backlighting	LED	LED
DisplayColors	From a palette of 68billion colors:- 10-bit (DisplayPort):1.07 billion colors(maximum)- 8-bit colors: 16.77million colors	From a palette of 68billion colors:- 10-bit (DisplayPort):1.07 billion colors(maximum)- 8-bit colors: 16.77million colors
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer
Video Signal Input
Input videosignals	DVI-D (dual link) x 2.DisplayPort x 2(two inputs are required)	DVI-D (dual link) x 1,DisplayPort x 1
ScanningFrequency(H. V)	31 - 129 kHz / 29 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz. 59- 61 Hz	31 - 127 kHz. 29 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz.59 - 61 Hz
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	225 W / Less than 6 W	125 W / Less than 3 W	The proposed deviceconsumes more powerdue to the larger panelsize.
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)	692 x 466 x 109 mm	376 x 505 x 98 mm	Different housing designdue to the different panelsize.

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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
Page 5 of 5

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Imgur

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 viewingdigital images for review and analysis by trained medicalpractitioners. It does not support the display of mammographyimages 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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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).