8MP Color LCD Monitor CL-R813

K222864 · Jvckenwood Corporation · PGY · Dec 21, 2022 · Radiology

Device Facts

• Record ID: K222864
• Device Name: 8MP Color LCD Monitor CL-R813
• Applicant: Jvckenwood Corporation
• Product Code: PGY · Radiology
• Decision Date: Dec 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

Device Story

32-inch 8MP Color LCD monitor; displays medical images for diagnostic review by trained practitioners. Input: digital video signals (DVI-D, DisplayPort). Transformation: utilizes IPS LCD panel with LED backlight; integrated luminance sensor and control circuit maintain stable luminance; lookup table applies DICOM GSDF grayscale characteristics; luminance mura correction ensures screen uniformity. Output: high-resolution visual display of medical images. Used in clinical environments; operated by physicians or certified personnel. Benefits: provides high-fidelity, calibrated visualization of diagnostic images to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical or animal data. Performance verified against FDA guidance for diagnostic radiology displays, including spatial resolution (MTF), pixel defects (ISO 13406-2), artifacts (AAPM-TG18), temporal response, luminance stability, DICOM GSDF conformance, color tracking, and gray tracking.

Technological Characteristics

32-inch IPS LCD panel; 3840 x 2160 resolution; LED backlight; 60Hz refresh rate; integrated luminance sensor; DICOM GSDF calibration; luminance mura correction; DVI-D and DisplayPort interfaces. Software: QA Medivisor Agent, FCAL.

Indications for Use

Indicated for trained medical practitioners or certified personnel to display and view medical images for diagnostic purposes. Not indicated for digital 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

• 21.3 inch (54.0cm) Color LCD Monitor CL-R211 (K182539)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

JVCKENWOOD Corporation Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 Japan

December 21, 2022

Re: K222864

Trade/Device Name: 8MP Color LCD Monitor CL-R813 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: December 14, 2022 Received: December 15, 2022

Dear Hideki Tengeiji:

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 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); 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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,
Jessica Low

Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K222864

Device Name 8MP Color LCD Monitor CL-R813

Indications for Use (Describe)

CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.

It is not meant to be used in digital mammography.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:none;stroke:#000000;stroke-width:1" width="15" x="0" y="0"></rect> <path d="M2 2 L13 13 M2 13 L13 2" stroke="#000000" stroke-width="1"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:none;stroke:#000000;stroke-width:1" width="15" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# K222864

# 510(k) SUMMARY

## I. Submitter

| Submitter: | JVCKENWOOD Corporation |
|-----------------|----------------------------------------|
| | 3-12, Moriya-cho, Kanagawa-ku, |
| | Yokohama-shi, Kanagawa, 221-0022 Japan |
| Contact Person: | Hideki Tengeiji, Senior Manager |
| | Email: [e-mail] |
| | Tel: [phone] |
| | Fax: [phone] |
| Date Prepared: | September 22, 2022 |

#### II. Device

| Name of Device: | 8MP Color LCD Monitor CL-R813 |
|-----------------------|----------------------------------------------------------------------------------------------|
| Common or Usual Name: | Display, diagnostic radiology |
| Classification Name: | Medical Image Management and Processing System<br>(Part 892 Radiology Devices Sec. 892.2050) |
| Regulatory Class | II |
| Product Code | PGY |

#### III. Predicate Device

| Name of Device: | 21.3 inch (54.0cm) Color LCD Monitor CL-R211 (K182539) |
|-----------------------|----------------------------------------------------------------------------------------------|
| Common or Usual Name: | Display, diagnostic radiology |
| Classification Name: | Medical Image Management and Processing System<br>(Part 892 Radiology Devices Sec. 892.2050) |
| Regulatory Class | II |
| Product Code | PGY |

# JVCKENWOOD

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## IV. Device Description

32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)

- Color LCD panel, which has wide view angle, is used for this product. It is designed for ■ medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance mura correction functions will help achieve uniformity on the whole screen.

#### V. Indications for use

CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

#### VI. Cybersecurity

FDA quidance located at https://www.fda.gov/media/86174/download, is followed for cybersecurity concerns.

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### VII. Comparison of Technological Characteristics with the predicate device

The comparison table below list information obtained from the product catalogs and measurements and different technological characteristics are discussed in it.

| | Predicate device<br>LCD Monitor CL-R211 | Proposed device<br>LCD Monitor CL-R813 | Explanation of<br>Differences |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182539 | - | - |
| Indication for use | CL-R211 is intended to be<br>used in displaying and viewing<br>medical images for diagnosis<br>by trained medical<br>practitioners or certified<br>personnel. It is not meant to<br>be used in digital<br>mammography. | CL-R813 is intended to be<br>used in displaying and<br>viewing medical images for<br>diagnosis by trained medical<br>practitioners or certified<br>personnel. It is not meant to<br>be used in digital<br>mammography. | - |
| Display Technology | IPS LCD panel with TFT<br>active-matrix array with LED<br>backlight | IPS LCD panel with TFT<br>active-matrix array with LED<br>backlight | - |
| Screen size | Diagonal: 21.3"<br>Aspect ratio: 4:3 | Diagonal: 32"<br>Aspect ratio: 16:9 | The display area of the<br>proposed device is larger<br>than that of the predicate<br>device. |
| Backlight type | LED | LED | - |
| Frame rate and refresh rate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 2MP (1200 x 1600) | 8MP (3840 × 2160) | The resolution of the<br>proposed device is higher<br>than that of the predicate<br>device. |
| Pixel Pitch | Horizontal: 0.270mm<br>Vertical: 0.270mm | Horizontal: 0.1845mm<br>Vertical: 0.1845mm | Pixel pitch of the<br>proposed device are<br>smaller than those of the<br>predicate device. |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 57 % | 57 % | - |
| Subpixel driving (spatial and<br>temporal dithering) | N/A | N/A | - |
| Display Interface | Input: DVI-D x1<br>DisplayPort x1<br>Output: DisplayPort x1 | Input: DVI-D x1<br>DisplayPort x2<br>Output: DisplayPort x1 | - |
| Video bandwidth | Dot clock: 162 MHz | Dot clock: 533.25 MHz | So the resolution of the<br>proposed device is higher<br>than that of the predicate<br>device, the dot clock of<br>the proposed device is<br>higher than that of the<br>predicate device |
| User control | DICOM CONFORMANCE TEST<br>Configuration switch<br>Input signal switch<br>Dynamic gamma<br>AUTO TEXT<br>Human presence sensor<br>EDID switch<br>Test pattern<br>USB Power | Config Select<br>Backlight<br>Contrast<br>Source Select<br>Human Sensor | Although the user<br>controls are different, the<br>performance of the<br>proposed device is the<br>same as the predicate<br>device. |
| Ambient light sensing | Built-in Sensor (For correction<br>during calibration) | Built-in Sensor (For<br>correction during calibration) | - |
| Touch-screen technology | N/A | N/A | - |
| Luminance calibration tools /<br>Quality-control procedures | Hardware:<br>Integrated sensor<br>External sensor<br>Software:<br>QA Medivisor/Medivisor NX<br>FCAL | Hardware:<br>Integrated sensor<br>External sensor<br>Software:<br>QA Medivisor Agent<br>FCAL | - |
| Additional Software/Firmware | N/A | N/A | - |

The above differences in technical characteristics do not affect the safety and the effectiveness of the CL-R813.

#### JVCKE OD

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#### VIII. Performance Test

The following performance tests were performed on the CL-R813 in accordance with the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017.

| Performance test items<br>in the guidance | Test method(s) |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital<br>camera equipped with a macro lens. The MTF is calculated<br>with the captured data. |
| b. Pixel defects (maximum<br>counts, allowed defect<br>types, and locations) | ISO 13406-2<br>IDMS 1.03, 7.6 DEFECTIVE PIXELS<br>Pixel defects are counted based on the ISO13406-2, 3.4.13<br>table 3. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests<br>IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME<br>Rise and fall time constants at four grayscale intervals (0-<br>100%, 5-95%, 10-90%, 40-60%) are provided by the<br>panel manufacturer. |
| e. Luminance (maximum,<br>minimum, achievable, and<br>recommended | Lmin and Lmax on the calibrated luminance are confirmed. |
| f. Conformance to a grayscale<br>to luminance function (e.g.,<br>DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response<br>Luminance response for 256 levels are measured. |
| (For color displays)<br>m. Color tracking (primary<br>colors and color gamut) | Color scale:<br>IDMS 1.03, 6. Gray- and Color-Scale Measurement<br>IDMS 1.03, 5.4 Color-Signal White<br>Color gamut volume:<br>IDMS 1.03, 5.31 Volume-Color-Reproduction Capability |
| (For color displays)<br>n. Gray tracking (gray shades<br>and white point) | AAPM-TG196 Gray Tracking<br>IEC 62563-1: 2009+AMD1:2016+AMD2:2021, 7.4.9<br>Greyscale chromaticity evaluation |

As a result of the performance test, it was confirmed that the CL-R813 has the equivalent display characteristics as the predicate device, CL-R211. The display characteristics of the CL-R813 meet the predefined criteria.

The CL-R813 has not been tested on animal or clinical testing.

#### IX. Conclusions

As shown above, the intended use of the subject device and the predicate device is identical, the technical characteristics are similar, and any differences in the characteristics do not affect the safety or effectiveness of the device. The results of the performance testing and the verification and validation demonstrate that the subject device is substantially equivalent to the predicate device currently on the market.