RadiForce GX570; RadiForce GX570-AR

{0} FDA U.S. FOOD & DRUG ADMINISTRATION 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} 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 {2} 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 {3} RadiForce GX570 Page 8 of 38 | 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. | | ? | | 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. | | | | 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) | ? | {4} K252030 EIZO EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan U.S. Food and Drug Administration Center for Devices and Radiological Health Name Hiroaki Hashimoto Department Regulatory Compliance and Safety Telephone +81 (76) 274-2468 E-Mail hiroaki.hashimoto@eizo.com # 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, I - Classification Name: Medical Image Management and Processing System (21 CFR 892.2050) - Regulatory Class: II - Product Code: PGY Section 05 510(k) Summary_GX570: Page 1 of 7 {5} Section 05 510(k) Summary_GX570: Page 2 of 7 ## 4. 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 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. 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. ## 5. 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. {6} # 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 | Section 05 510(k) Summary_GX570: Page 3 of 7 {7} 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 | | RadiiCS | 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: RadiiCS | Photo Diode Position: In the upper bezel of the screen Software tool: RadiiCS | | Touch-screen technology | | | | | N/A | N/A | | Luminance calibration tools | | | | | Integrated optical sensor | Integrated optical sensor | {8} | | 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. Section 05 510(k) Summary_GX570: Page 5 of 7 {9} 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. Section 05 510(k) Summary_GX570: Page 6 of 7 {10} 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. Section 05 510(k) Summary_GX570: Page 7 of 7