6MP Color LCD Monitor CL-S600

K212985 · Jvckenwood Corporation · PGY · Dec 16, 2021 · Radiology

Device Facts

• Record ID: K212985
• Device Name: 6MP Color LCD Monitor CL-S600
• Applicant: Jvckenwood Corporation
• Product Code: PGY · Radiology
• Decision Date: Dec 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CL-S600 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

6MP Color LCD monitor (30-inch) for medical image display; inputs digital video signals via DisplayPort; utilizes IPS LCD panel with LED backlight; features integrated luminance sensor and control circuit for stabilization; performs luminance and color mura correction; displays images according to DICOM GSDF grayscale characteristics. Used in clinical environments by trained medical practitioners or certified personnel. Provides high-resolution visual output for diagnostic review. Includes user-selectable functions: Pixel Enhancer, Turbo Luminance, Dynamic Range Extension, Human Presence Sensor, and Reading Light. Benefits include consistent, calibrated image quality for diagnostic accuracy.

Clinical Evidence

Bench testing only. Performance verified against AAPM-TG18, ISO 13406-2, IDMS 1.03, and IEC 62563-1 standards. Tests included spatial resolution (MTF), pixel defects, artifacts, temporal response, luminance stability, DICOM GSDF conformance, color tracking, and gray tracking.

Technological Characteristics

30-inch IPS LCD panel, TFT active-matrix, LED backlight. Resolution 3280 x 2080 (6MP). Connectivity: DisplayPort input/output. Integrated luminance sensor for calibration. Software tools: QA Medivisor Agent, FCAL. Cybersecurity follows FDA guidance. Standards: ISO 13406-2, AAPM-TG18, IDMS 1.03, IEC 62563-1.

Indications for Use

Indicated for trained medical practitioners or certified personnel for displaying and viewing 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

• CCL650i2 (CL30650/ K140214)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

December 16, 2021

#### Re: K212985

Trade/Device Name: 6MP Color LCD Monitor CL-S600 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: September 27, 2021 Received: September 30, 2021

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K212985

Device Name 6MP Color LCD Monitor CL-S600

Indications for Use (Describe)

CL-S600 is intended to be used in displaying and viewing medical images for 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

Submitted Information: 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 14, 2021 6MP Color LCD Monitor CL-S600 Device Name: Common Name: display, diagnostic radiology Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Medical Image Management and Processing System 30 inch (76.8cm) Color LCD Monitor CCL650i2 Predicate Device: (CL30650/ K140214) Device Description: 30 inch Color LCD Monitor 3280 x 2080 (landscape) ■ High-luminance 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 and the color mura correction functions will help achieve uniformity on the whole screen.

#### JVCKENWOOD Corporation

K212985

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## JVCKENWOOD

| Cybersecurity: | FDA guidance located at<br>https://www.fda.gov/media/86174/download, is followed for<br>cybersecurity concerns. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | CL-S600 is intended to be used in displaying and viewing medical<br>images for diagnosis by trained medical practitioners or certified<br>personnel. It is not meant to be used in digital mammography. |
| Substantial Equivalence: | CL-S600 shares the same technical characteristics, application,<br>and intended use as our predicate device CCL650i2<br>(CL30650/ K140214) |

JVCKENWOOD Corporation

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### Device Description & Substantial Equivalence Comparison

| | Predicate device<br>LCD Monitor CL30650 | Proposed device<br>LCD Monitor CL-S600 | Explanation of<br>Differences |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K140214 | - | - |
| Indication for use | CL30650 is intended to be used in<br>displaying and viewing medical images for<br>diagnosis by trained Medical practitioners.<br>It is not meant to be used in digital<br>mammography. | CL-S600 is intended to be used in<br>displaying and viewing medical images for<br>diagnosis by trained medical practitioners<br>or certified personnel. It is not meant to be<br>used in digital mammography. | - |
| Display Technology | IPS LCD panel with TFT active-matrix<br>array with LED backlight | IPS LCD panel with TFT active-matrix<br>array with LED backlight | - |
| Screen size | Diagonal: 30"<br>Aspect ratio: 16:9.99 | Diagonal: 30"<br>Aspect ratio: 16:10.15 | The display area of the proposed device is<br>wider than the predicate device.<br>Compared to the predicate device, the<br>proposed device has a larger display area. |
| Backlight type | LED | LED | - |
| Frame rate and refresh<br>rate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 6MP (3280 x 2048) | 6MP (3280 × 2080) | The resolution of the proposed device is<br>larger than that of the predicate device. |
| Pixel Pitch | Horizontal: 0.197mm<br>Vertical: 0.197mm | Horizontal: 0.197mm<br>Vertical: 0.197mm | - |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 43.0% | 46.5 % | Almost the same. |
| Subpixel driving (spatial<br>and temporal dithering) | N/A | N/A | - |
| Display Interface | Input:<br>DVI-D x2<br>DisplayPort x2<br>Output:<br>N/A | Input:<br>DisplayPort x2<br>Output:<br>DisplayPort x1 | The proposed device is not equipped with<br>a DVI-D input, but this is not a problem<br>since graphics cards are no longer<br>equipped with a DIV-D output. |
| Video bandwidth | Dot clock: 443.52 MHz | Dot clock: 443.52 MHz | - |
| | Predicate device<br>LCD Monitor CL30650 | Proposed device<br>LCD Monitor CL-S600 | Explanation of<br>Differences |
| User controls | Input signal switch<br>EDID switch<br>Dynamic gamma<br>AUTO TEXT<br>Test pattern<br>Configuration switch,<br>INPUT SOURCE AUTO SCANNING | Input signal switch<br>Dynamic gamma<br>AUTO TEXT<br>Test pattern<br>Configuration switch<br>Pixel Enhancer<br>Turbo Luminance<br>Dynamic Range Extension<br>Auto Config Select<br>Human Presence Sensor<br>Reading Light<br>USB Power | The functions in the predicate device are<br>also available in the proposed device.<br>Regarding "EDID switch", the proposed<br>device can automatically switch EDID. |
| Ambient light sensing | Built-in Sensor (For correction during<br>calibration) | Built-in Sensor (For correction during<br>calibration) | - |
| Touch-screen<br>technology | N/A | N/A | - |
| Luminance calibration<br>tools / Quality-control<br>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<br>Software/Firmware | N/A | N/A | - |

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### Physical Laboratory Tests

| Performance test items in the guidance | Test method(s) |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital camera<br>equipped with a macro lens. The MTF is calculated with the<br>captured data. |
| b. Pixel defects (maximum counts, allowed<br>defect 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 (0-100%,<br>5-95%, 10-90%, 40-60%) are provided by the panel<br>manufacturer. |
| e. Luminance<br>(maximum, minimum, achievable, and<br>recommended) | $L_{min}$ and $L_{max}$ on the calibrated luminance are confirmed. |
| f. Conformance to a grayscale-to-<br>luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response<br>Luminance response for 256 levels are measured. |
| (For mammography displays)<br>g. Luminance at 30° and 45° in diagonal,<br>horizontal, and vertical directions at center<br>and four corners | N/A |
| (For mammography displays)<br>h. Luminance uniformity or Mura test | N/A |
| (For mammography displays)<br>i. Stability of luminance and chromaticity<br>response with temperature and time of<br>operation or on-time | N/A |
| (For mammography displays)<br>j. Spatial noise | N/A |
| (For mammography displays)<br>k. Reflection coefficient | N/A |
| (For mammography displays)<br>l. Veiling glare or small-spot contrast | N/A |
| (For color displays)<br>m. Color tracking (primary colors and color<br>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 and white<br>point) | AAPM-TG196 Gray Tracking<br>IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale<br>chromaticity evaluation |

#### Conclusion

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