This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Device Description

RadiForce GX570 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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.

The Digital Uniformity Equalizer function compensates luminance non-uniformity, one of the inherent characteristics of LCD panel modules, to the levels required by various QC standards and guidelines.

The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).

There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.

Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce GX570 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 GX570.

RadiCS is of Basic Documentation Level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce GX570 and it's not a medical imaging software.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary are for a medical display monitor (RadiForce GX570), not an AI device or a diagnostic algorithm. Therefore, the information requested regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document discusses the technical performance of a display monitor, such as:

Spatial resolution (MTF)
Pixel defects
Luminance and chromaticity (including DICOM GSDF conformance)
Temporal response
Noise (NPS)
Display reflections
Small-spot contrast ratio

These are physical and optical performance characteristics of a display hardware, not the diagnostic performance of a software algorithm.

Therefore, I cannot populate the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment, as this information is not relevant to a medical display monitor clearance.

The document does state that the device is intended for use with "clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners." However, the studies described are bench tests to assure the display hardware meets performance standards for displaying these images, not for interpreting them with AI.

Summary

FDA 510(k) Clearance Letter - RadiForce GX570 Medical Display Monitors

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 28, 2025

EIZO Corporation
Hiroaki Hashimoto
Senior Manager of Regulatory Compliance and Safety Department
153 Shimokashiwano
Hakusan, Ishikawa, 924-8566
Japan

Re: K252030
Trade/Device Name: RadiForce GX570; RadiForce GX570-AR
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: PGY
Dated: June 30, 2025
Received: June 30, 2025

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"

Page 2

K252030 - Hiroaki Hashimoto Page 2

(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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

Page 3

K252030 - Hiroaki Hashimoto Page 3

(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-devices/device-advice-comprehensive-regulatory-assistance/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
Assistant Director
Imaging Software Team
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

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K252030

Please provide the device trade name(s).

RadiForce GX570; RadiForce GX570-AR

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

RadiForce GX570 Page 8 of 38

Page 5

K252030

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

Name: Hiroaki Hashimoto
Department: Regulatory Compliance and Safety

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Telephone: +81 (76) 274-2468
E-Mail: hiroaki.hashimoto@eizo.com

Section 05 510(k) Summary_GX570: Page 1 of 7

510(k) Summary

1. Submitter

EIZO Corporation
153 Shimokashiwano, Hakusan,
Ishikawa 924-8566 Japan
Phone: +81 (76) 274-2468
Contact Person: Hiroaki Hashimoto
Date of Prepared: June 27th, 2025

2. Device

Name of Device: RadiForce GX570; RadiForce GX570-AR
Common or Usual Name: 54.1 cm (21.3 inch) class Monochrome 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 GX560, GX560-AR (K181609)
Common or Usual Name: 54.1 cm (21.3 inch) class Monochrome LCD Monitor
Classification Name: Medical Image Management and Processing System (21 CFR 892.2050)
Regulatory Class: II
Product Code: PGY
Name of Device: RadiForce GX540 (K151883)
Common or Usual Name: 5MP Monochrome LCD Monitor
Classification Name: Medical Image Management and Processing System (21 CFR 892.2050)
Regulatory Class: II
Product Code: PGY

Page 6

Section 05 510(k) Summary_GX570: Page 2 of 7

4. Device Description

The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).

There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.

Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.

5. Indications for use

Page 7

Section 05 510(k) Summary_GX570: Page 3 of 7

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 GX570	Predicate Device: RadiForce GX560
Indications for Use	This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.	This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Display Technology	TFT Monochrome LCD Panel (IPS)	TFT Monochrome LCD Panel (IPS)
Screen size	54.1cm / 21.3" Aspect ratio: 4 : 5	54.1cm / 21.3" Aspect ratio: 4 : 5
Backlight type	LED	LED
Frame rate and refresh rate
Digital Scanning Frequency (H / V)	31 - 135 kHz / 23 - 61 Hz Frame synchronous mode: 23.5 - 25.5 Hz, 47 - 51 Hz	31 - 135 kHz / 23 - 61 Hz Frame synchronous mode: 23.5 - 25.5 Hz, 47 - 51 Hz
Pixel pitch
Pixel pitch	0.165 mm x 0.165 mm	0.165 mm x 0.165 mm
Subpixel pattern	-	-
Pixel aperture ratio	0.602	0.541
Subpixel driving (spatial and temporal dithering)
Independent Subpixel drive	OFF	OFF
Dithering	Normal Mode：4bitFRC Sub-Pixel drive Mode：3bitFRC	4bit FRC
Display Interface
Input video signals	DVI-D (dual link) x 1, DisplayPort x 2	DVI-D (dual link) x 1, DisplayPort x 2
Output video signals	DisplayPort x 1 (daisy chain)	DisplayPort x 1 (daisy chain)
Video bandwidth	DVI : 25-290MHz DisplayPort : 25-290MHz	DVI : 290MHz DisplayPort : 290MHz

Page 8

Section 05 510(k) Summary_GX570: Page 4 of 7

User controls
OSD	CAL Switch / FineContrast / Color Mode	CAL Switch / FineContrast / Color Mode
	Mode Skip	Mode Skip
	Brightness	Brightness
	Contrast	SelfQC
	Gamma	Sharpness Recovery
	SelfQC	DP Daisy Chain
	Sharpness Recovery	Orientation(H/W Pivot)
	DP Daisy Chain	Sub Pixel Drive
	Orientation(H/W Pivot)	Power Save
	Sub Pixel Drive	DP Power Save
	Power Save	EcoView Sense
	DP Power Save	Language
	Language	OSD Information
	OSD Information	Indicator
	Indicator	Input Selection
	Input Selection	Logo
	Key Lock	Key Lock
	LEA (Life Expectancy Analyzer)	LEA (Life Expectancy Analyzer)
	USB Selection for KVM Switch	USB Selection for KVM Switch
	Grayscale Warning	Grayscale Warning
RadiCS	Complete QC Tests	Complete QC Tests
	Calibration	Calibration
	Task Setting	Task Setting
	History Management	History Management
	Asset Management	Asset Management
Ambient light sensing
Ambient light sensor	Photo Diode Position: In the upper right bezel of the screen Software tool: RadiCS	Photo Diode Position: In the upper bezel of the screen Software tool: RadiCS
Touch-screen technology
	N/A	N/A
Luminance calibration tools
	Integrated optical sensor	Integrated optical sensor

Page 9

Section 05 510(k) Summary_GX570: Page 5 of 7

	External optical sensor Calibration software: RadiCS	External optical sensor Calibration software: RadiCS
Quality-control procedures
	Software: RadiCS AAPM On-line Report No. 03:2005 compliant	Software: RadiCS AAPM On-line Report No. 03:2005 compliant
Software/Firmware
	N/A	N/A

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the GX570.

Page 10

Section 05 510(k) Summary_GX570: Page 6 of 7

7. Performance Testing

The bench tests below were performed on the RadiForce GX570 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 the angular dependency of luminance response in horizontal, vertical and diagonal directions
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
Performance data on luminance stability
Measurement of noise expressed as noise power spectrum (NPS)
Measurement of display reflections including specular, diffuse and haze components
Measurement of small-spot contrast ratio

The test results showed that the RadiForce GX570 has display characteristics equivalent to those of the predicate device, RadiForce GX560 or RadiForce GX540.

Besides, the display characteristics of the RadiForce GX570 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce GX570.

Page 11

Section 05 510(k) Summary_GX570: Page 7 of 7

8. Conclusion

The RadiForce GX570 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).