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 RX250 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.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX250" such as "RX250-AR", a model with an Anti-Reflective coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX250 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 RX250.

AI/ML Overview

The provided FDA 510(k) summary for the EIZO RadiForce RX250 and RX250-AR 2MP Color LCD Monitor describes the acceptance criteria and the study performed to demonstrate its performance.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance for each individual test in a clear, side-by-side format. However, it lists several performance tests and states that the device "meet the pre-defined criteria when criteria are set" and that its display characteristics are "equivalent to those of the predicate device, RadiForce RS240."

Based on the descriptions, we can infer some criteria and implied performance:

Acceptance Criteria Category	Implied/Inferred Specific Criteria (based on tests)	Reported Device Performance
DICOM Conformance	Conformance to DICOM GSDF as specified by AAPM TG18 guideline	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Verification of the conformance to DICOM GSDF...")
Luminance Uniformity	Non-uniformity characteristics as specified in TG18 guideline	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of the luminance non-uniformity characteristics of the display screen...")
Chromaticity Uniformity	Non-uniformity characteristics as specified in TG18 guideline	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of the chromaticity non-uniformity characteristics of the display screen...")
Chromaticity Accuracy	Chromaticity at 5%, 50%, and 95% of maximum luminance within acceptable range	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance")
Visual Artifacts	Absence of miscellaneous artifacts on the display screen as specified in TG18 guideline	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Visual check of presence or absence of miscellaneous artifacts on the display screen...")
Spatial Resolution (MTF)	Meeting specified Modulation Transfer Function (MTF) criteria	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of spatial resolution expressed as modulation transfer function (MTF)")
Pixel Defects/Faults	Maximum number allowed for each type of pixel defects/faults	The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "The maximum number allowed for each type of pixel defects/faults")
Overall Equivalence to Predicate Device (RadiForce RS240)	Technological characteristics do not affect safety and effectiveness; display characteristics are equivalent.	Confirmed that technological characteristics different from the predicate device do not affect safety and effectiveness. Bench tests demonstrated that display characteristics are equivalent to those of the predicate device and meet pre-defined criteria.

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

Sample Size: The document does not specify a distinct "test set" sample size in terms of number of monitors. The tests were performed "on the RadiForce RX250," implying that these are type tests performed on a representative sample of the device, rather than a statistical sampling of a large population of monitors.
Data Provenance: This is a physical device (monitor), not an AI algorithm processing medical images. Therefore, "data provenance" in terms of "country of origin of the data" or "retrospective/prospective" is not applicable in the same way it would be for a software device. The tests are bench tests performed on the manufactured device itself.

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

Not applicable. This is a medical display device, and its performance evaluation involves objective physical measurements and conformance to standards (like AAPM TG18), not interpretation by medical experts establishing ground truth for clinical images.

4. Adjudication Method for the Test Set

Not applicable. As this is a physical device undergoing objective bench testing against established technical standards, there is no need for an adjudication method typically used for subjective clinical assessments or AI algorithm outputs.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a medical display monitor itself.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not an algorithm. The "standalone" performance here refers to the monitor's characteristics measured directly by test equipment without human visual interpretation as the primary measurement. The listed tests are indeed measurements of the monitor's physical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance evaluation is established by objective technical standards and guidelines, primarily:

AAPM Task Group 18 (TG18 guideline): "Assessment of Display Performance for Medical Imaging Systems."
DICOM GSDF (Grayscale Standard Display Function): A specific tone curve for medical displays.

The device's performance is measured against the specifications and acceptable ranges defined by these standards, not against clinical outcomes or expert consensus on medical images shown on the display.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (LCD monitor), not a machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this hardware device.

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a family of three people.

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

February 23, 2016

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

Re: K160247

Trade/Device Name: 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 28, 2016 Received: February 1, 2016

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, 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.

Michael D. O'Hara

For

Robert Ochs. Ph.D. 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) K160247

Device Name

2MP Color LCD Monitor, RadiForce RX250, RX250-AR

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is a square divided into smaller squares, with a jagged edge at the top. The "O" in "EIZO" has a registered trademark symbol next to it.

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

Hiroaki Hashimoto Name Department 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 27th, 2016

4. Device Information

RadiForce RX250, RX250-AR ● Trade Name/Model:
Common Name: 2MP Color LCD Monitor ●
Classification Name: Display, Diagnostic Radiology .
Regulation Number: 21 CFR 892.2050, Product Code PGY ●

5. Predicate Device

2MP Color LCD Monitor, RadiForce RS240 (K150106) ●

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6. Device Description

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX250" such as "RX250-AR", a model with an Anti-Reflective coating.

7. Indications for 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	RadiForceRX250 / RX250-AR	RadiForceRS240	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	IPS TFT Color LCDPanel	IPS TFT Color LCDPanel	-
Viewingangle (H, V)	H: 178°, V: 178°	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	800 cd/m²	-
DICOMcalibratedluminance	400 cd/m²	400 cd/m²	-
Contrast ratio	1400 : 1	1400 : 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 Signals
Input videosignals	DVI-D x 1,DisplayPort x 1	DVI-D x 1,DisplayPort x 1	-
Outputvideosignals	DisplayPort x 1 (daisychain)	-	-
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 / 60Hz	AC 100 - 240 V: 50 / 60Hz	-
PowerConsumption/ Save Mode	79 W / Less than 1.0 W	79 W / Less than 1.6 W	-
PowerManagement	DVI DMPM,DisplayPort 1.2a	DVI DMPM,DisplayPort 1.1a	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor,Presence Sensor,Integrated Front SensorAmbient Light Sensor	Backlight Sensor,Presence 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)	361 x 465 x 78 mm	376 x 505 x 98 mm	Different housing design.

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX250.

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9. Performance Testing

The following bench tests were performed on the RadiForce RX250.

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 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
Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in 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 RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240.

Besides, the display characteristics of the RadiForce RX250 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX250.

10. Conclusion

The RadiForce RX250 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.

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).