This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Device Description

RadiForce MX194 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs Vertical Alignment (VA) technology allowing high contrast ratio and the matrix size (or resolution) is 1,280 x 1,024 pixels (1MP) with a pixel pitch of 0.294 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX194 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 MX194.

AI/ML Overview

The RadiForce MX194 is a color LCD monitor indicated for displaying radiological images for review, analysis, and diagnosis by trained medical practitioners, excluding mammography.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (RadiForce MX194)
Spatial Resolution	Measurement of MTF (Modulation Transfer Function)	Equivalent to predicate device (RadiForce MX215)
Pixel Defects	Maximum number allowed for each type of pixel defects/faults	Met pre-defined criteria
Artifacts	Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline	Met pre-defined criteria
Temporal Response	Measurement of temporal response	Met pre-defined criteria
Luminance	Measurement of luminance	Met pre-defined criteria
DICOM GSDF Conformance	Verification of conformance to DICOM GSDF as specified in TG18 guideline	Met pre-defined criteria
Color Tracking	Measurement of color tracking	Met pre-defined criteria
Overall Display Characteristics	Display characteristics equivalent to the predicate device, RadiForce MX215	Confirmed

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for algorithmic performance. The performance testing described refers to bench tests conducted on the RadiForce MX194 device itself. Therefore, a specific sample size for a test set of medical images or data provenance is not applicable here as this is a display device, not an AI/ML algorithm that processes patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a display monitor, and the testing involved bench tests of its physical and performance characteristics, not an evaluation of diagnostic accuracy using a ground truth established by medical experts for image interpretation.

4. Adjudication method for the test set

Not applicable. This device is a display monitor, and the testing involved bench tests of its physical and performance characteristics, not an evaluation of diagnostic accuracy.

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 document describes a display monitor, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a display monitor, not an algorithm.

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

For the performance testing of the RadiForce MX194, the "ground truth" was established by pre-defined criteria and industry guidelines such as the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and the AAPM Task Group 18 (TG18 guideline). These guidelines specify objective measurements and visual criteria for evaluating display device performance. There was no medical ground truth based on patient outcomes or expert diagnoses, as this is a hardware device.

8. The sample size for the training set

Not applicable. This document is for a medical display device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This document is for a medical display device, not an AI/ML algorithm that requires a training set and corresponding ground truth.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described under "7. Performance Testing" in the 510(k) summary.

Study Design:

The study was a series of bench tests performed on the RadiForce MX194. The tests followed the instructions outlined in the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (issued October 2, 2017) and the "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)".

Tests Performed:

The following specific tests were conducted:

Measurement of spatial resolution expressed as modulation transfer function (MTF)
Evaluation of pixel defects/faults (maximum number allowed for each type)
Visual check for the presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
Measurement of temporal response
Measurement of Luminance
Verification of conformance to DICOM GSDF as specified in the TG18 guideline
Measurement of Color tracking

Results:

The test results demonstrated that:

The RadiForce MX194 has display characteristics equivalent to those of its predicate device, RadiForce MX215.
The display characteristics of the RadiForce MX194 meet the pre-defined criteria established as acceptance criteria for each test.

Conclusion of the Study:

The performance testing concluded that the RadiForce MX194 is substantially equivalent to the predicate device (RadiForce MX215) and meets all pre-defined performance criteria, confirming its safety and effectiveness for its intended use. No animal or clinical testing was performed for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

May 10, 2018

Re: K180961

Trade/Device Name: RadiForce MX194 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 10, 2018 Received: April 12, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Page 2 - Hiroaki Hashimoto

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mechonl 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) K180961

Device Name RadiForce MX194

Indications for Use (Describe)

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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

Research Use (Per 21 CFR 201.128) or Screening Purposes
As Therapeutic Use (21 CFR part 312)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the EIZO logo. 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 gray, three-dimensional object with a checkered pattern on its face. The "EIZO" text is in black, and there is a registered trademark symbol to the upper right of the letter "O".

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 Requlatory Compliance and Safety

Telephone Fax E-Mail

+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com

510(k) Summary

1. Submitter

EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Fax: +81 (76) 274-2484

Contact Person: Hiroaki Hashimoto Date of Prepared: April 10th, 2018

2. Device

Name of Device: RadiForce MX194 ●
Common or Usual Name: 48.1 cm (19.0 inch) class Color LCD Monitor ●
Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) ●
Regulatory Class: II
Product Code: PGY

3. Predicate Device

EIZO Corporation RadiForce MX215 (K131090)

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4. Device Description

5. Indications for use

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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6. Comparison of Technological Characteristics with the predicate device

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

Attributes	Proposed Device:RadiForce MX194	Predicate Device:RadiForce MX215
Display Technology	TFT ColorLCD Panel (VA)	TFT ColorLCD Panel (IPS)
Screen size	48.1cm / 19.0"Aspect ratio: 5 : 4	54cm / 21.3"Aspect ratio: 3 : 4
Backlight type	LED	LED
Frame rate and refresh rate
Digital Scanning Frequency(H / V)	31 - 64 kHz / 59 - 61 Hz	31 - 100 kHz / 59 - 61 Hz
Analog Scanning Frequency(H / V)	24.8 - 80 kHz / 50 - 75 Hz	26 - 100 kHz / 49 - 76 Hz
Display Interface
Input video signals	DVI-D x 1,DisplayPort x 1,D-Sub mini 15 pin x 1	DVI-I x 1,DisplayPort x 1
Video bandwidth
	DVI : 108MHzDisplayPort : 108MHzAnalog : 135MHz	DVI : 164.5MHzDisplayPort : 164.5MHzAnalog : 164.5MHz
Ambient light sensing
Ambient light sensor	Yes	Yes
Luminance calibration tools
	Integrated optical sensorExternal optical sensorCalibration software:RadiCS	Integrated optical sensorExternal optical sensorCalibration software:RadiCS
Quality-control procedures
	Software: RadiCS	Software: RadiCS

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX194.

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7. Performance Testing

The bench tests below were performed on the RadiForce MX194 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:

. Measurement of spatial resolution expressed as modulation transfer function (MTF)
The maximum number allowed for each type of pixel defects/faults .
. Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
Measurement of temporal response
Measurement of Luminance ●
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 Color tracking

The test results showed that the RadiForce MX194 has display characteristics equivalent to those of the predicate device, RadiForce MX215.

Besides, the display characteristics of the RadiForce MX194 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX194.

8. Conclusion

The RadiForce MX194 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 or 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).