RadiForce RX360, RX360-AR

K182591 · Eizo Corporation · PGY · Oct 18, 2018 · Radiology

Device Facts

• Record ID: K182591
• Device Name: RadiForce RX360, RX360-AR
• Applicant: Eizo Corporation
• Product Code: PGY · Radiology
• Decision Date: Oct 18, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

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 Story

RadiForce RX360/RX360-AR is a 21.3-inch color LCD monitor (3MP resolution) for medical image viewing. Device receives video signals via DVI-D or DisplayPort from a workstation; internal lookup tables apply factory-calibrated tone curves (DICOM GSDF compliant) to ensure accurate luminance and color reproduction. RX360 features anti-glare treatment; RX360-AR features anti-reflection coating. Used in clinical settings by radiologists/physicians for diagnostic review. RadiCS software, installed on the workstation, performs quality control, quantitative/visual tests, and calibration via integrated/external optical sensors. Device provides high-fidelity visual output to support clinical diagnostic decision-making; benefits include consistent image quality and adherence to AAPM TG18 guidelines.

Clinical Evidence

No clinical or animal testing performed. Bench testing only, conducted per FDA guidance 'Display Devices for Diagnostic Radiology' (2017). Metrics included MTF, pixel defect analysis, artifact assessment, temporal response, luminance, DICOM GSDF conformance, and color tracking.

Technological Characteristics

54.1cm (21.3") color IPS LCD; 1,536 x 2,048 resolution; LED backlight; DVI-D and DisplayPort interfaces; integrated optical sensor for calibration; RadiCS software for QC; DICOM GSDF compliant; anti-glare (RX360) or anti-reflection (RX360-AR) surface treatment.

Indications for Use

Indicated for trained medical practitioners to display radiological images for review, analysis, and diagnosis. Not for mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• RadiForce RX350 (K153354)

Submission Summary (Full Text)

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October 18, 2018

EIZO Corporation Hiroaki Hashimoto Senior Manager 153 Shimokashiwano HAKUSAN, 924-8566 JAPAN

Re: K182591

Trade/Device Name: RadiForce RX360, RX360-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: September 14, 2018 Received: September 20, 2018

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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182591

Device Name RadiForce RX360, RX360-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) | <div style="display:inline-block;">X</div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;"></div> |

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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 a bold, sans-serif font on the right. The geometric shape is composed of squares and jagged edges, giving it a textured appearance. The "EIZO" text is followed by the registered trademark symbol.

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

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

| Name | Hiroaki Hashimoto |
|------------|-------------------------------------|
| Department | Regulatory Compliance and<br>Safety |
| Telephone | [phone] |
| Fax | [phone] |
| E-Mail | [e-mail] |

# 510(k) Summary

### 1. Submitter

EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: [phone] Fax: [phone]

Contact Person: Hiroaki Hashimoto Date of Prepared: September 14th, 2018

### 2. Device

●

- Name of Device: RadiForce RX360, RX360-AR
- Common or Usual Name: 54.1 cm (21.3 inch) class Color LCD Monitor ●
- Classification Name: Picture archiving and communications system . (21 CFR 892.2050)
- Regulatory Class: II
- . Product Code: PGY

### 3. Predicate Device

EIZO Corporation RadiForce RX350 (K153354)

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## 4. Device Description

RadiForce RX360 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 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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.

There are two model variations, RX360 and RX360-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX360 is Anti-Glare (AG) treatment and that of the RX360-AR is Anti-Reflection (AR) coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX360 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX360.

#### 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 of the each device and different technological characteristics are discussed in it:

| Attributes | Proposed Device:<br>RadiForce RX360 | Predicate Device:<br>RadiForce RX350 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Display Technology | Color (IPS) | Color (IPS) |
| Screen size | 54.1cm / 21.3"<br>Aspect ratio: 3 : 4 | 54.1cm / 21.3"<br>Aspect ratio: 3 : 4 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | 31 - 127 kHz / 29 - 61.5 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous mode: 29.5<br>- 30.5 Hz, 59 - 61 Hz | 31 - 127 kHz / 29 - 61.5 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous mode: 29.5<br>- 30.5 Hz, 59 - 61 Hz |
| Display Interface | | |
| Input video<br>signals | DVI-D (dual link) x 1,<br>DisplayPort x 2 | DVI-D (dual link) x 1,<br>DisplayPort x 1 |
| Output video<br>signals | DisplayPort x 1 (daisy chain) | DisplayPort x 1 (daisy chain) |
| Video bandwidth | DVI : 215MHz<br>DisplayPort : 215MHz | DVI : 215MHz<br>DisplayPort : 215MHz |
| Ambient light sensing | | |
| Ambient light sensor | Yes | Yes |
| Luminance calibration tools | | |
| | Integrated optical sensor<br>External optical sensor<br>Calibration software:<br>RadiCS | Integrated optical sensor<br>External optical sensor<br>Calibration software:<br>RadiCS |
| Quality-control procedures | | |
| | Software: RadiCS<br>AAPM On-line Report<br>No.<br>03:2005 compliant | Software: RadiCS<br>AAPM On-line<br>Report<br>No.<br>03:2005 compliant |

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX360.

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## 7. Performance Testing

The bench tests below were performed on the RadiForce RX360 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:

- 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 RX360 has display characteristics equivalent to those of the predicate device. RadiForce RX350.

Besides, the display characteristics of the RadiForce RX360 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX360.

#### 8. Conclusion

The RadiForce RX360 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.