RadiForce MX247W

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 1, 2026 Eizo Corporation Hiroaki Hashimoto Senior Manager of Regulatory Compliance and Safety Department 153 Shimokashiwano Hakusan, Ishikawa, 924-8566 Japan Re: K262783 Trade/Device Name: RadiForce MX247W Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: August 6, 2026 Received: August 6, 2026 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262783 - Hiroaki Hashimoto Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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 (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 {2} K262783 - Hiroaki Hashimoto Page 3 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 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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K262783 Device Name RadiForce MX247W 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."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} [LOGO] 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 K262783 # 1. Submitter EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Contact Person: Hiroaki Hashimoto Date of Prepared: August 6th, 2026 # 2. Device - Name of Device: RadiForce MX247W - Common or Usual Name: 24.1" (61.0 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 MX243W (K221136) - 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 Section 05 510(k) Summary_MX247W_b: Page 1 of 7 {5} #### 4. Device Description RadiForce MX247W 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 (2MP) 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 diagnostic monitors including the RadiForce MX247W 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 MX247W. 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 MX247W and it's not a medical imaging software. #### 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. Section 05 510(k) Summary_MX247W_b: Page 2 of 7 {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 MX247W | Predicate Device: RadiForce MX243W | | --- | --- | --- | | **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. | 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. | | **Display Technology** | | | | | TFT Color LCD Panel (IPS) | TFT Color LCD 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** | | | | Digital Scanning Frequency (H / V) | Digital: 31 - 76 kHz / 59 - 61 Hz Frame synchronous mode: 59 – 61 Hz | Digital: 31 - 76 kHz / 59 - 61 Hz Frame synchronous mode: 59 – 61 Hz | | **Pixel pitch** | | | | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | | Subpixel pattern | RGB Vertical Stripe | RGB Vertical Stripe | | Pixel aperture ratio | 0.678 | 0.637 | | **Subpixel driving (spatial and temporal dithering)** | | | | Independent Subpixel drive | N/A | N/A | | Dithering | 5bit FRC | 5bit FRC | | **Display Interface** | | | | Input video signals | DisplayPort x 1, HDMI x 1 | DVI-D (single link) x 1, DisplayPort x 1 | | Output video signals | DisplayPort x 1 (daisy chain) | DisplayPort x 1 (daisy chain) | | **Video bandwidth** | | | | | HDMI : 25-165 MHz DisplayPort : 25 - 165 MHz | DVI : 25-165 MHz DisplayPort : 25 - 165 MHz | | **User controls** | | | Section 05 510(k) Summary_MX247W_b: Page 3 of 7 {7} | OSD | CAL Switch / FineContrast / Color Mode | CAL Switch / FineContrast / Color Mode | | --- | --- | --- | | | Mode Skip | Mode Skip | | | Hybrid Gamma PXL | Hybrid Gamma PXL | | | Brightness | Brightness | | | Contrast | Contrast | | | Temperature | Temperature | | | Gamma | Gamma | | | Hue | Hue | | | Saturation | Saturation | | | Gain | Gain | | | SelfQC | Picture Expansion | | | Picture Expansion | Sharpness Recovery | | | Sharpness Recovery | DP Daisy Chain | | | DP Daisy Chain | Power Save | | | Standby Mode | DP Power Save | | | DP Power Save | Language | | | Language | Orientation | | | Orientation | OSD Information | | | OSD Information | Indicator | | | Reset | Input Selection | | | Indicator | Key Lock | | | Input Selection | Grayscale Warning | | | Key Lock | | | | LEA (Life Expectancy Analyzer) | | | | Grayscale Warning | | | | Limited Range 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 bezel of the screen | N/A | Section 05 510(k) Summary_MX247W_b: Page 4 of 7 {8} | | Software tool: RadiCS | | | --- | --- | --- | | **Touch-screen technology** | | | | | N/A | N/A | | **Luminance calibration tools** | | | | | Integrated optical sensor External optical sensor Calibration software: RadiCS | Integrated optical sensor 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 MX247W. Section 05 510(k) Summary_MX247W_b: Page 5 of 7 {9} ## 7. Performance Testing The bench tests below were performed on the RadiForce MX247W 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 MX247W has display characteristics equivalent to those of the predicate device, RadiForce MX243W. Besides, the display characteristics of the RadiForce MX247W meet the pre-defined criteria when criteria are set. No animal or clinical testing was performed on the RadiForce MX247W. Section 05 510(k) Summary_MX247W_b: Page 6 of 7 {10} ## 8. Conclusion The RadiForce MX247W 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_MX247W_b: Page 7 of 7