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 RX670 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 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1986 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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

There are two model variations. RX670 and RX670-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX670 is Anti-Glare (AG) treatment and that of the RX670-AR is Anti-Reflection (AR) coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce RX670 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX670.

RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX670 and it's not a medical imaging software.

AI/ML Overview

The provided document, K241441, is a 510(k) premarket notification for the RadiForce RX670 and RadiForce RX670-AR medical display monitors. The document demonstrates substantial equivalence to predicate devices (RadiForce RX660, RX660-AR, and RadiForce RS340) for displaying radiological images for review, analysis, and diagnosis, excluding mammography.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to "pre-defined criteria" but does not explicitly list the numerical acceptance criteria for each test. Instead, it states that the device "meet[s] the pre-defined criteria when criteria are set" and that its display characteristics are "equivalent to those of the predicate device."

Acceptance Criteria	Reported Device Performance (RadiForce RX670)
Spatial Resolution (MTF)	Demonstrated display characteristics "equivalent to those of the predicate device."
Pixel Defects/Faults (Maximum allowed number)	Demonstrated display characteristics "equivalent to those of the predicate device."
Miscellaneous Artifacts (Visual check based on TG18 guideline)	Demonstrated display characteristics "equivalent to those of the predicate device."
Temporal Response	Demonstrated display characteristics "equivalent to those of the predicate device."
Luminance	Demonstrated display characteristics "equivalent to those of the predicate device."
Conformance to DICOM GSDF (as per AAPM TG18 guideline)	Demonstrated display characteristics "equivalent to those of the predicate device."
Color Tracking	Demonstrated display characteristics "equivalent to those of the predicate device."

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

Sample Size: The document does not explicitly state the number of RadiForce RX670 units tested. It refers to "the RadiForce RX670" (singular), implying that one or more units of the product were subjected to the specified bench tests.
Data Provenance: The testing was "bench tests," conducted by the manufacturer, EIZO Corporation, in Japan. The data is thus prospective, originating from the manufacturer's internal testing.

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 as the study involved bench tests of a medical display device, not a study evaluating human interpretation of images or an AI algorithm's diagnostic performance against a ground truth.

4. Adjudication method for the test set:

This information is not applicable as the study involved bench tests of a medical display device, not a study requiring adjudication of expert opinions or diagnostic outcomes.

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 document is for a medical display device, not an AI-powered diagnostic algorithm.

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

No, a standalone algorithm performance study was not done. This document is for a medical display device, which is hardware, and its associated quality control software (RadiCS). It does not involve a diagnostic algorithm.

7. The type of ground truth used:

This information is not applicable in the traditional sense of diagnostic accuracy studies. For the bench tests, the "ground truth" would be the engineering specifications and established standards (e.g., DICOM GSDF, AAPM TG18 guideline) against which the display's performance characteristics were measured.

8. The sample size for the training set:

This information is not applicable. The device is a display monitor, not an AI algorithm that requires a training set. The RadiCS software mentioned is for quality control and "is not a medical imaging software" and "it's being used unchanged from the predicate software," implying no new algorithm development or training.

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

This information is not applicable for the reasons stated in point 8.

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

EIZO Corporation Hiroaki Hashimoto Senior Manager of Regulatory Compliance and Safety Department 153 Shimokashiwano HAKUSAN, ISHIKAWA, 924-8566 JAPAN

July 16, 2024

Re: K241441

Trade/Device Name: RadiForce RX670; RadiForce RX670-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: May 22, 2024 Received: May 22, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241441

Device Name

RadiForce RX670;

RadiForce RX670-AR

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 with a checkered pattern and jagged edges. The "®" symbol is located to the upper right of the letter "O" in "EIZO".

EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa924-8566 Japan	NameDepartment	Hiroaki HashimotoRegulatory Compliance andSafety
U.S. Food and Drug AdministrationCenter for Devices and Radiological Health	Telephone	+81 (76) 274-2468
	E-Mail	hiroaki.hashimoto@eizo.com

510(k) Summary K241441

1. Submitter

EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Contact Person: Hiroaki Hashimoto Date of Prepared: May 20th, 2024

2. Device

Name of Device: RadiForce RX670; RadiForce RX670-AR
Common or Usual Name: 30.0 inch (76.2 cm) Color LCD Monitor ●
. Classification Name: Medical Image Management and Processing System (21 CFR 892.2050)
Regulatory Class: ● II
. Product Code: PGY

3. Predicate Device

Name of Device: RadiForce RX660, RX660-AR (K163335)
Common or Usual Name: 6MP Color LCD Monitor ●
Classification Name: Medical Image Management and Processing System ● (21 CFR 892.2050)
Regulatory Class: II
Product Code: PGY
Name of Device: RadiForce RS340 (K143098) ●
Common or Usual Name: 3MP 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 RX670	Predicate Device:RadiForce RX660
Indications for Use	This Product is indicated for usein displaying radiological imagesfor review, analysis, and diagnosisby trained medical practitioners.The display is not intended formammography.	This product is intended to beused in displaying and viewingdigital images for review, analysisand diagnosis by trained medicalpractitioners. It does not supportthe display of mammographyimages for diagnosis.
Display Technology	TFT ColorLCD Panel (IPS)	TFT ColorLCD Panel (IPS)
Screen size	76.2cm / 30.0"Aspect ratio: 16 : 10	76.0cm / 30.0"Aspect ratio: 16 : 10
Backlight type	LED	LED
Frame rate and refresh rate
Digital Scanning Frequency(H / V)	31 - 127 kHz /VGA TEXT: 69 - 71Hz, ExceptVGA TEXT:59 - 61Hz,Frame synchronous mode: 59 - 61Hz	31 - 127 kHz / 22 - 61Hz (DVI),29 - 61Hz (DisplayPort), VGATEXT: 69 - 71Hz (DVI,DisplayPort)Frame synchronous mode: 29.5 –30.5 Hz, 59 - 61 Hz
Display Interface
Input videosignals	USB Type-C (DisplayPort AltMode) x 1,DisplayPort x 2,HDMI x 1	DVI-D (dual link) x 1,DisplayPort x 2
Output videosignals	USB Type-C (daisy chain) x 1	DisplayPort x 1 (daisy chain)
Video bandwidth	(HDMI)25-440MHz(DisplayPort)25-440MHz(DisplayPort Alt Mode Input(onUSB Type-C))	(DVI)Single Display:Except LM derivation: 25-240MHzLM derivation: 25-280MHzUp to 165MHz: Single LinkOver 165MHz: Dual Link
	25-440MHz	Up to 165MHz: Single LinkOver 165MHz: Dual Link
		(DisplayPort)DP1 Port Single Display: 25-440MHzPbyP/PinP: 25-240MHzDP2 Port: 25-240MHz
Ambient light sensing
Ambient light sensor	Photo DiodePosition: In the upper bezel of thescreen	Photo DiodePosition: In the upper bezel of thescreen
	Software tool: RadiCS	Software tool: RadiCS
Luminance calibration tools
	Integrated optical sensorExternal optical sensorCalibration software:RadiCS	Integrated optical sensorExternal optical sensorCalibration software:RadiCS
Quality-control procedures
	Software: RadiCS	Software: RadiCS

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX670.

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7. Performance Testing

The bench tests below were performed on the RadiForce RX670 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28, 2022:

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 RX670 has display characteristics equivalent to those of the predicate device, RadiForce RX660.

Besides, the display characteristics of the RadiForce RX670 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX670.

8. Conclusion

The RadiForce RX670 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).