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K Number
K233465
Device Name
RadiForce MX317W
Manufacturer
EIZO Corporation
Date Cleared
2023-12-21

(58 days)

Product Code
PGYLLZ
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
RadiForce MX317W 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 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 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. RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce MX317W based on the OC 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 MX317W. RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX317W and it's not a medical imaging software.
More Information

K170949, K113844

Not Found

No
The description focuses on the hardware (LCD monitor) and basic software for quality control (RadiCS). There is no mention of AI or ML capabilities for image analysis or processing.

No
The device is a display monitor used for viewing radiological images for diagnosis, not for treating any condition.

Yes

The device is indicated for use in "displaying radiological images for review, analysis, and diagnosis by trained medical practitioners," which falls under the definition of a diagnostic device.

No

The primary device described is a color LCD monitor (RadiForce MX317W), which is a hardware component. While the submission includes software (RadiCS) as an accessory, the core device for which performance studies are presented is a physical display.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." This describes a device used to visualize medical images, not a device used to perform tests on biological samples (which is the core function of an IVD).
  • Device Description: The description details a color LCD monitor designed for viewing medical images. It focuses on display technology, resolution, calibration, and quality control software. None of these aspects relate to the analysis of biological specimens.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Reagents or kits
    • Analysis of biological samples (blood, urine, tissue, etc.)
    • Measurement of biomarkers or analytes
    • Diagnostic tests performed on samples

The device is clearly a medical image display monitor, which falls under a different regulatory category than IVDs.

N/A

Intended Use / 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.

Product codes

PGY

Device Description

RadiForce MX317W 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 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce MX317W based on the OC 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 MX317W.

RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX317W and it's not a medical imaging software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical practitioners

Description of the training set, sample size, data source, and annotation protocol

No animal or clinical testing was performed on the RadiForce MX317W.

Description of the test set, sample size, data source, and annotation protocol

No animal or clinical testing was performed on the RadiForce MX317W.

Summary of Performance Studies

The bench tests below were performed on the RadiForce MX317W 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 MX317W has display characteristics equivalent to those of the predicate device, RadiForce MX315W.

Besides, the display characteristics of the RadiForce MX317W meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX317W.

Key Metrics

Not Found

Predicate Device(s)

K170949, K113844

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a sans-serif font.

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

Re: K233465

December 21, 2023

Trade/Device Name: RadiForce MX317W Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: October 24, 2023 Received: October 24, 2023

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).

1

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 medical devices and radiation-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 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

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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)

K233465

Device Name

RadiForce MX317W

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."

3

Image /page/3/Picture/1 description: The image shows the logo for EIZO. On the left side of the logo is a gray, geometric shape that resembles a flag or banner. The right side of the logo shows the company name, "EIZO", in a bold, sans-serif font. There is a registered trademark symbol next to the "O" in "EIZO".

EIZO Corporation, 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

NameHiroaki Hashimoto
DepartmentRegulatory Compliance and Safety
Telephone+81 (76) 274-2468
E-Mailhiroaki.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: November 17th, 2023

2. Device

  • Name of Device: RadiForce MX317W
  • Common or Usual Name: 30.5 inch (77.5 cm) Color LCD Monitor
  • Classification Name: Display, Diagnostic Radiology
    • (21 CFR 892.2050)
  • Regulatory Class: II
  • . Product Code: PGY

3. Predicate Device

  • Name of Device: RadiForce MX315W (K170949) ●
  • Common or Usual Name: 79.0 cm (31.1 inch) class Color LCD Monitor
  • Classification Name: Display, Diagnostic Radiology ●
  • (21 CFR 892.2050) Regulatory Class: ● II
  • Product Code: PGY
  • Name of Device: RadiForce RX240 (K113844) ●
  • Common or Usual Name: 2MP Color LCD Monitor
  • Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) ● Regulatory Class: II
  • Product Code: LLZ

4

4. Device Description

RadiForce MX317W 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 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce MX317W based on the OC 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 MX317W.

RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX317W 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.

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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 MX317W | Predicate Device:
RadiForce MX315W |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 intended to be used
in displaying and viewing digital
images for review, analysis and
diagnosis by trained medical
practitioners. It does not support
the display of mammography
images for diagnosis. |
| Display Technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) |
| Screen size | 77.5cm / 30.5"
Aspect ratio: 17 : 9 | 79.0cm / 31.1"
Aspect ratio: 17 : 9 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | | |
| Digital Scanning Frequency
(H / V) | USB Type-C: 31 - 134 kHz / 59

  • 61 Hz
    DisplayPort: 31 - 134 kHz / 59 -
    61 Hz
    HDMI: 31 - 136 kHz / 59 - 61
    Hz | 31 - 134 kHz / 14 - 61 Hz |
    | Display Interface | | |
    | Input video
    signals | USB Type-C (DisplayPort Alt
    Mode) x 1,
    DisplayPort x 2,
    HDMI x 1 | DVI-D x 1,
    DisplayPort x 2 |
    | Output video
    signals | USB Type-C (daisy chain) x 1 | DisplayPort x 1 (daisy chain) |
    | Video bandwidth | | |
    | | HDMI : 25-600MHz
    DisplayPort : 25-570MHz
    DisplayPort Alt Mode Input(on
    USB Type-C) : 25-570MHz | DP1 Port Single Display: 25-
    570MHz
    PbyP/PinP: 25-300MHz
    DP2 Port Single Display: Not
    supported
    PbyP/PinP: 25-300MHz
    Up to 288MHz: 8/10bit color |
    | Ambient light sensing | | |
    | Ambient light sensor | Photo Diode
    Position: In the upper bezel of the screen
    Software tool: RadiCS | Photo Diode
    Position: In the upper bezel of the screen
    Software tool: RadiCS |
    | 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 | Software: RadiCS |

6

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX317W.

7. Performance Testing

The bench tests below were performed on the RadiForce MX317W 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 MX317W has display characteristics equivalent to those of the predicate device, RadiForce MX315W.

Besides, the display characteristics of the RadiForce MX317W meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX317W.

7

8. Conclusion

The RadiForce MX317W 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.