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 MX243W 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 1,920 x 1,200 pixels (2.3MP) with a pixel pitch of 0.270 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 MX243W 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 MX243W.

RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX243W and it's not a medical imaging software.

AI/ML Overview

The provided document is a 510(k) summary for the EIZO RadiForce MX243W medical display. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance testing of the display itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies (sample size for test/training set, data provenance, number/qualifications of experts, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable to this submission.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the RadiForce MX243W's display characteristics meet "pre-defined criteria when criteria are set" and are "equivalent to those of the predicate device, RadiForce MX242W." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported performance values. It only lists the types of tests performed.

Acceptance Criteria (General Statement)	Reported Device Performance (General Statement)
Display characteristics meet pre-defined criteria.	The RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W.
	The display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set.

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

This is not applicable as the submission is for a medical display, not an AI/ML device that operates on patient data. The tests were performed on the physical display unit.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert labels on medical images) does not apply to the performance testing of a monitor. The tests performed are objective measurements based on established guidelines.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the purpose of this submission (a medical display).

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

No, a standalone performance study was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for display performance testing refers to objective physical standards and measurements rather than expert consensus on medical findings. The tests performed are based on guidelines such as the AAPM TG18 guideline and "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The manufacturer performed bench tests on the RadiForce MX243W medical display. These tests were conducted following the instructions in the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and referenced the AAPM Task Group 18 (TG18) guideline for assessment of display performance.

The specific tests performed include:

Measurement of spatial resolution (Modulation Transfer Function - MTF)
Evaluation of pixel defects/faults
Visual check for miscellaneous artifacts on the display screen (as specified in TG18)
Measurement of temporal response
Measurement of Luminance
Verification of conformance to DICOM GSDF (as specified in TG18)
Measurement of pixel aperture ratio
Measurement of Color tracking

The document states that the "test results showed that the RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W" and that "the display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set."

No animal or clinical testing was performed for this device. The conclusion is that the device is substantially equivalent to its predicate based on its intended use, that technological differences do not affect safety or effectiveness, and that the bench tests demonstrated equivalent display characteristics.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K221136

Trade/Device Name: RadiForce MX243W Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: April 14, 2022 Received: April 19, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221136

Device Name RadiForce MX243W

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)

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 logo for EIZO. To the left of the company name is a graphic of a square with a checkered pattern. The company name is in all caps and to the right of the name is the registered trademark symbol.

oration, 153 Shimokashiwano, Hakusan, Ishikawa

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	Hiroaki Hashimoto
Department	Regulatory Compliance andSafety
Telephone	+81 (76) 274-2468
E-Mail	hiroaki.hashimoto@eizo.com

510(k) Summary K221136

1. Submitter

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

Contact Person: Hiroaki Hashimoto Date of Prepared: April 14th, 2022

2. Device

Name of Device: RadiForce MX243W
Common or Usual Name: 61 cm (24.1 inch) class Color LCD Monitor
Classification Name: Medical image management and processing system ● (21 CFR 892.2050) II
Regulatory Class:
Product Code: PGY

3. Predicate Device

Name of Device: RadiForce MX242W (K143261) ●
Common or Usual Name: 61 cm (24.1 inch) class Color LCD Monitor ●
Classification Name: Medical image management and processing system (21 CFR 892.2050)
- Regulatory Class: II
● Product Code: PGY

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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 and measured values of the each device and different technological characteristics are discussed in it:

Attributes	Proposed Device:RadiForce MX243W	Predicate Device:RadiForce MX242W
Display Technology	TFT ColorLCD Panel (IPS)	TFT ColorLCD Panel (IPS)
Screen size	61cm / 24.1"Aspect ratio: 16 : 10	61cm / 24.1"Aspect ratio: 16 : 10
Backlight type	LED	LED
Frame rate and refresh rate
Scanning Frequency(H / V)	Digital: 31 - 76 kHz / 59 - 61 HzFrame synchronous mode: 59 - 61 Hz	Digital: 31 - 76 kHz / 59 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronous mode: 59 - 61 HzAnalog: 26 - 76 kHz / 49 - 71 Hz(VGA Text: 69 - 71 Hz)Frame synchronous mode: 59 - 61 Hz
Display Interface
Input video signals	DVI-D (single link) x 1,DisplayPort x 1	DVI-I x 1,DisplayPort x 1
Output video signals	DisplayPort x 1 (daisy chain)	-
Video bandwidth	DVI : 25-165 MHzDisplayPort : 25 - 165 MHz	DVI-I (Analog): 25-165 MHzDVI-I (Digital): 165MHz max.DisplayPort: 165MHz max.
Ambient light sensing
Ambient light sensor	N/A	N/A
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 MX243W.

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7. Performance Testing

The bench tests below were performed on the RadiForce MX243W 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 pixel aperture ratio
Measurement of Color tracking ●

The test results showed that the RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W.

Besides, the display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX243W.

8. Conclusion

The RadiForce MX243W 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).