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

Device Description

RadiForce RS240 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 and the matrix size (or resolution) is 1,200 x 1,600 pixels (2MP).

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 RS240 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 RS240.

AI/ML Overview

The provided text describes the 510(k) summary for the EIZO RadiForce RS240 monitor, which is a display device for medical images. It's important to note that this document is for a medical monitor, not an AI-powered diagnostic device or software. Therefore, many of the requested criteria related to AI performance, ground truth, and human reader studies are not applicable to this submission.

Based on the provided text, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Tests Performed)	Reported Device Performance
Conformance to DICOM GSDF (as specified in AAPM TG18 guideline)	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.
Measurement of luminance non-uniformity characteristics (as specified in TG18 guideline)	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.
Measurement of chromaticity non-uniformity characteristics (as specified in TG18 guideline)	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.
Measurement of chromaticity at center of display at 5%, 50%, and 95% of maximum luminance (as specified in FDA Guidance for FM)	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.
Visual check of presence or absence of miscellaneous artifacts (as specified in TG18 guideline)	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.
Measurement of spatial resolution (expressed as Modulation Transfer Function - MTF)	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.
Maximum number allowed for pixel defects/faults	The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance. The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of patient data or images. The testing described refers to bench tests of the monitor's performance characteristics. Therefore, there's no sample size of images or data provenance in the way one would describe for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The testing was for the technical performance of a display device, not for diagnostic accuracy evaluated against a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.

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
Not applicable. This is a medical display device, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical display device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a medical display device would be the established technical standards (e.g., DICOM GSDF, TG18 guidelines) against which its performance is measured, not clinical diagnostic ground truth.

8. The sample size for the training set
Not applicable. There is no AI model or training set involved for a medical display device.

9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved for a medical display device.

Summary of Device and Study Type:

The EIZO RadiForce RS240 is a 2MP Color LCD Monitor intended for displaying digital medical images for review, analysis, and diagnosis by trained medical practitioners (excluding mammography images). The study conducted was a series of bench tests to verify the monitor's technical specifications and conformance to industry standards (like AAPM TG18 guideline and FDA guidance for display accessories). The primary goal was to demonstrate substantial equivalence to a predicate device (RadiForce RX240) by showing that any technological differences do not affect safety or effectiveness, and that its display characteristics meet pre-defined criteria. There was no animal or clinical testing performed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 3, 2015

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

Re: K150106

Trade/Device Name: 2MP Color LCD Monitor, RadiForce RS240 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 9, 2015 Received: January 20, 2015

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. 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K150106

Device Name 2MP Color LCD Monitor, RadiForce RS240

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the EIZO logo. The logo consists of a stylized square shape with a checkered pattern on the left and the word "EIZO" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the "O" in "EIZO".

EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Janan

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 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

2. Contact Person

Hiroaki Hashimoto

1. Date of Summary January 16th, 2015

4. Device Information

Trade Name/Model: RadiForce RS240 ●
2MP Color LCD Monitor ● Common Name:
Classification Name: Display, Diagnostic Radiology ●
21 CFR 892.2050, Product Code PGY ● Regulation Number:

5. Predicate Device

2MP Color LCD Monitor, RadiForce RX240 (K113844) ●

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6. Device Description

7. Intended Use

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

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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:

Attributes	RadiForceRS240	RadiForceRX240	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	IPS TFT Color LCDPanel	IPS TFT Color LCDPanel	-
Viewingangle (H, V)	H: 176°, V: 176°	H: 176°, V: 176°	Typical data for very lowcontrast provided by thepanel manufacturer iscited.
Resolution	2MP (1,200 x 1,600)	2MP (1,200 x 1,600)	-
Aspect ratio	3 : 4	3 : 4	-
Active screensize	324.0 mm x 432.0 mm	324.0 mm x 432.0 mm	-
Pixel pitch	0.270 mm x 0.270 mm	0.270 mm x 0.270 mm	-
Maximumluminance	800 cd/m²	760 cd/m²	-
DICOMcalibratedluminance	400 cd/m²	400 cd/m²	-
Contrast ratio	1400 : 1	1200 : 1	Typical contrast ratio dataprovided by panelmanufacturers is cited.
Backlighting	LED	LED	-
DisplayColors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	-
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer	-
Video Signal Input
Input videosignals	DVI-D x 1,DisplayPort x 1	DVI-D x 1,DisplayPort x 1	-
ScanningFrequency(H, V)	31 - 100 kHz / 59 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 59 - 61 Hz	31 - 100 kHz / 59 – 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 59 - 61 Hz	-
Power Related Specifications
PowerRequirements	AC 100 - 240 V: 50 / 60 Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	-
PowerConsumption/ Save Mode	79 W / Less than 1.6 W	105 W / Less than 1.6 W	-
PowerManagement	DVI DMPM,DisplayPort 1.1a	DVI DMPM,DisplayPort 1.1a	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor,Presence Sensor	Backlight Sensor,Presence Sensor,Integrated Front Sensor(IFS),Ambient Light Sensor	The both devices arecapable of QC tests andcalibration with anexternal 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)	376 x 505 x 98 mm	376 x 505 x 98 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 RS240.

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9. Performance Testing

The following bench tests were performed on the RadiForce RS240.

. 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
Measurement of spatial resolution expressed as modulation transfer function (MTF)
. The maximum number allowed for each type of pixel defects/faults

The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240 except some items, each of which was determined that it would not affect observer's performance.

Besides, the display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RS240.

10. Conclusion

The RadiForce RS240 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 different 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 except some items, each of which was determined that it would not affect observer's performance.

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).