5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

K191137 · Jvckenwood Corporation · PGY · Jul 2, 2019 · Radiology

Device Facts

• Record ID: K191137
• Device Name: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
• Applicant: Jvckenwood Corporation
• Product Code: PGY · Radiology
• Decision Date: Jul 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Device Story

CL-S500 (color) and MS-S500 (monochrome) are 21.3-inch LCD monitors for medical image display; used in digital mammography, breast tomosynthesis, and FFDM. Devices receive video input via DVI-D or DisplayPort; transform signals using internal lookup tables to ensure grayscale characteristics conform to DICOM GSDF. Integrated luminance sensors and control circuits maintain stable luminance; uniformity correction function minimizes luminance/color unevenness across screen. Operated by physicians/certified personnel in clinical environments. Output provides high-resolution medical images for diagnostic decision-making. Benefits include consistent, calibrated image quality for accurate radiological interpretation.

Clinical Evidence

Bench testing only. Performance validated against AAPM-TG18 guidelines for luminance response, spatial resolution, uniformity, chromaticity, and stability. Pixel defects evaluated per ISO13406-2 and VESA 2001 standards. No clinical data required for this monitor classification.

Technological Characteristics

21.3-inch TFT IPS LCD panels; LED backlighting; 5MP (2048x2560) resolution; 4:5 aspect ratio. Connectivity: DVI-D, DisplayPort, USB 2.0. Features: built-in front and ambient light sensors, luminance stabilization circuit, digital uniformity correction. Power: 100-240V AC. Standards: DICOM GSDF, AAPM-TG18, ISO13406-2, VESA 2001.

Indications for Use

Indicated for trained medical practitioners or certified personnel for displaying and viewing medical images in digital mammography PACS, digital breast tomosynthesis, and FFDM modalities.

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

• LCD Monitor CCL550i2 (K160326)

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). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The logo is simple and clean, and it is easily recognizable.

July 2, 2019

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

### Re: K191137

Trade/Device Name: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: June 3, 2019 Received: Jun 5, 2019

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K191137

Device Name 5MP Color LCD Monitor CL-S500 5MP Monochrome LCD Monitor MS-S500

Indications for Use (Describe)

CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

| Type of Use (Select one or both, as applicable) | <div> <span> <span style="text-decoration: line-through;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) SUMMARY

Submitted Information: JVC KENWOOD 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] May 23, 2019 Date Prepared: CL-S500 Device Name: 5MP Color LCD Monitor 5MP Monochrome LCD Monitor MS-S500 Common Name: CL-S500 (CL-S500xxxxx) MS-S500 (MS-S500xxxxx) Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) 21.3 inch (54cm) Color LCD Monitor CCL550i2(CL21550) Predicate Device: (CCL550i2/ K160326) Requlation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: PGY Device Description: CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait) ■ 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. ■ It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of

JVC KENWOOD Corporation

K191137

Healthcare Business Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan

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luminance and color on the whole screen.

■ Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted

MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait) ■ High-luminance monochrome 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. It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen. ■ Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted. CL-S500 and MS-S500 are intended to be used in displaying and Intended Use: viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS. digital breast tomosynthesis and modalities including FFDM. Substantial Equivalence: CL-S500 and MS-S500 share the same technical characteristics, application, and intended use as our predicate device CCL550i2/ K160326. CL-S-500 and MS-S500 are substantially equivalent to the predicate Conclusion: device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are the same as those of the predicate device, and other differences have been independently validated. Any differences

JVC KENWOOD Corporation

between the devices do not affect safety or effectiveness.

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## Substantial Equivalence Comparison

| | Predicate device<br>LCD Monitor CCL550i2<br>(CL21550) | LCD Monitor CL-S500 | Explanation of<br>Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K160326 | K191137 | - |
| Indication for use | CCL550i2 is intended to be<br>used in displaying and<br>viewing medical images for<br>diagnosis by trained medical<br>practitioners.<br>It is to be used in digital<br>mammography PACS, digital<br>breast tomosynthesis and<br>modalities including FFDM. | CL-S500 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.<br>It is intended to be used in<br>digital mammography PACS,<br>digital breast tomosynthesis<br>and modalities including<br>FFDM. | - |
| Response Time<br>(typical) | 25ms (On/Off) | 25ms (On/Off) | - |
| Resolution or<br>Matrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| Maximum Luminance | Min.700cd/m²<br>Typ. 1000cd/m² | Min. 920cd/m²<br>Typ. 1,150cd/m² | The maximum luminance of the predicate device is<br>Min.700cd/m² and one of CL-S500 is Min.920cd/m².<br>Therefore, CL-S500 is equivalent to or better than the<br>predicate device. |
| DICOM<br>Calibrated Luminance | 500cd/m² | 500cd/m² | The calibrated luminance is the same between CL-S500<br>and the predicate device. It's 500cd/m². |
| Viewing Angle | CR>50<br>Horizontal: Typ.176<br>Vertical: Typ.176 | CR>50<br>Horizontal: Typ.178<br>Vertical: Typ.178 | Compared with the predicate device, CL-S500 is<br>equivalent to or better than the predicate device. |
| Display Area | Horizontal: 337.92mm<br>Vertical: 422.4mm | Horizontal: 337.92mm<br>Vertical: 422.4mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | Horizontal: 0.165mm<br>Vertical: 0.165mm | Horizontal: 0.165mm<br>Vertical: 0.165mm | - |
| Contrast Ratio | Min.1000 : 1<br>Typ. 1300 : 1 | Min.1600 : 1<br>Typ. 2000 : 1 | The contrast ratio is the predicate device is Typ.1300:1,<br>and the one of the proposed device CL-S500 is<br>Typ.1600:1. Therefore, CL-S500 is equivalent to or<br>better than the predicate device. |
| Grayscale Tones | 10-bit (DisplayPort): 1,024<br>from a palette of 65,473<br>tones<br>8-bit: 256 from a palette of<br>65,473 tones | 10-bit (DisplayPort): 1.073 billion<br>1024 from a palette of 16,369<br>tones<br>8-bit(DVI): 16.77 million 256<br>from a palette of 16,369<br>tones | - |
| Non-Uniformity<br>Compensation | Digital Uniformity correction<br>System | Digital Uniformity correction<br>System | - |
| Input Video Signal | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | - |
| Scanning Frequency | Portrait:<br>Horizontal:129.1KHz<br>Vertical:50Hz<br>Landscape:<br>Horizontal:103.5KHz<br>Vertical:50Hz | Portrait:<br>Horizontal:129.1KHz<br>Vertical:50Hz<br>Landscape:<br>Horizontal:103.5KHz<br>Vertical:50Hz | - |
| Dot Clock | 285 MHz | 285 MHz | - |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | - |
| Power Consumption | 95W<br>Less than 2W | 95W<br>Less than 1W | - |
| Power Management | DVI DMPM,<br>DisplayPort 1.1a | DVI DMPM,<br>DisplayPort 1.2a | - |
| QA Software | QA Medivisor / Medivisor NX<br>F-CAL | QA Medivisor / Medivisor NX<br>F-CAL | - |
| Sensor | Built-in Front Sensor | Built-in Front Sensor | - |
| | Built-in ambient Light Sensor | Built-in ambient Light Sensor | - |
| | | | |
| USB Ports / Standard | 1 upstream,<br>2 downstream / Rev. 2.0 | 1 upstream,<br>2 downstream / Rev. 2.0 | - |
| Dimensions<br>w/o Stand<br>(W x H x D) | (AR, N) 474.5 x 390 x 98.1 mm<br>(F) 474.5 x 390 x 103.7 mm | (G) 361.5 x 517/612 x 196.5 mm | - |

This comparison table shows the differences on the technical characteristics between the proposed device. <CL-S500>

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## <MS-S500>

| | Predicate device<br>LCD Monitor CCL550i2<br>(CL21550) | LCD Monitor MS-S500 | Explanation of<br>Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K160326 | K191137 | - |
| Indication for use | CCL550i2 is intended to be<br>used in displaying and<br>viewing medical images for<br>diagnosis by trained medical<br>practitioners.<br>It is to be used in digital<br>mammography PACS, digital<br>breast tomosynthesis and<br>modalities including FFDM. | MS-S500 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.<br>It is intended to be used in<br>digital mammography PACS,<br>digital breast tomosynthesis<br>and modalities including<br>FFDM. | - |
| Response Time<br>(typical) | 25ms (On/Off) | 25ms (On/Off) | - |
| Resolution or<br>Matrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Monochrome LCD Panel<br>(IPS) | The difference between monochrome and color |
| Backlighting | LED | LED | - |
| Maximum Luminance | Min.700cd/m2<br>Typ. 1000cd/m2 | Min. 2,400cd/m2<br>Typ. 3,000cd/m2 | The maximum luminance of the predicate device is<br>Min.700cd/m2 and one of MS-S500 is Min.2400cd/m2. |
| DICOM<br>Calibrated Luminance | 500cd/m² | 1,000 cd/m² | Therefore, MS-S500 is equivalent to or better than the<br>predicate device.<br>The calibrated luminance of the predicate device is<br>Min.500cd/m² and one of MS-S500 is Min.1000cd/m².<br>Therefore, MS-S500 is equivalent to or better than the<br>predicate device. |
| Viewing Angle | CR>50<br>Horizontal: Typ.176<br>Vertical: Typ.176 | CR>50<br>Horizontal: Typ.178<br>Vertical: Typ.178 | Compared with the predicate device, MS-S500 is<br>equivalent to or better than the predicate device. |
| Display Area | Horizontal: 337.92mm<br>Vertical: 422.4mm | Horizontal: 337.92mm<br>Vertical: 422.4mm | |
| Aspect Ratio | 4:5 | 4:5 | |
| Pixel Pitch | Horizontal: 0.165mm<br>Vertical: 0.165mm | Horizontal: 0.165mm<br>Vertical: 0.165mm | |
| Contrast Ratio | Min.1000 : 1<br>Typ. 1300 : 1 | Min.1600 : 1<br>Typ.2000 : 1 | The contrast ratio is the predicate device is Typ.1300:1,<br>and the one of the proposed device MS-S500 is<br>Typ.2000:1. Therefore, MS-S500 is equivalent to or<br>better than the predicate device. |
| Grayscale Tones | 10-bit (DisplayPort): 1,024<br>from a palette of 65,473<br>tones<br>8-bit: 256 from a palette of<br>65,473 tones | 10-bit (DisplayPort): 1,024<br>from a palette of 16,369<br>tones<br>8-bit (DVI) : 256 from a<br>palette of<br>16,369 tones | Maximum bit depth by DisplayPort is 10 bit, and one by<br>DVI is 8 bit.<br>Tone between the predicate device and our proposed<br>devices are different. But they pass the exams in<br>AAPM-TG18 4.3 "Luminance Response".<br>Therefore, they are equivalent to the predicate device. |
| Non-Uniformity<br>Compensation | Digital Uniformity correction<br>System | Digital Uniformity correction<br>System | |
| Input Video Signal | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | |
| Scanning Frequency | Portrait:<br>Horizontal:129.1KHz<br>Vertical:50Hz<br>Landscape:<br>Horizontal:103.5KHz<br>Vertical:50Hz | Portrait:<br>Horizontal:129.1KHz<br>Vertical:50Hz<br>Landscape:<br>Horizontal:103.5KHz<br>Vertical:50Hz | |
| Dot Clock | 285 MHz | 285 MHz | |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | |
| | | | |
| Power Consumption | 95W<br>Less than 2W | 80W<br>Less than 1W | - |
| Power Management | DVI DMPM,<br>DisplayPort 1.1a | DVI DMPM,<br>DisplayPort 1.2a | - |
| QA Software | QA Medivisor / Medivisor NX<br>F-CAL | QA Medivisor / Medivisor NX<br>F-CAL | - |
| Sensor | Built- in Front Sensor<br>Built-in ambient Light Sensor | Built- in Front Sensor<br>Built-in ambient Light Sensor | - |
| USB Ports / Standard | 1 upstream,<br>2 downstream / Rev. 2.0 | 1 upstream,<br>2 downstream / Rev. 2.0 | - |
| Dimensions<br>w/o Stand<br>(W x H x D) | (AR, N) 474.5 x 390 x 98.1 mm<br>(F) 474.5 x 390 x 103.7 mm | (G) 361.5 x 517/612 x 196.5 mm | - |

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### Recommended Physical Laboratory Tests

| Measurements<br>Guidance | MS-S500, CL-S500<br>Measurements |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| a. Spatial resolution | MTF measurement method that uses a bar-pattern<br>image.<br>(Rectangle chart method) |
| b. Pixel defects<br>(maximum counts, allowed defect<br>types, and locations) | ISO13406-2 and Flat Panel Display Measurement<br>Standard [VESA 2001] were used. |
| c. Artifacts | Artifacts (phase or clock, ringing, ghosting, image<br>sticking, etc.) |
| d. Temporal response | JVC KENWOOD uses typical data provided by the<br>panel manufacturer.<br>(5-95%, 10-90%, 40-60%) |
| e. Luminance<br>(maximum, minimum, achievable,<br>and recommended) | Lmin, and Lmax on the calibrated luminance was<br>confirmed by the requirement of the "Luminance<br>Response" test of AAPM-TG18. |
| f. Conformance to a grayscale-to-<br>luminance function<br>(e.g., DICOM GSDF) | Luminance Response at 256 digital values by<br>AAPM-TG18 |
| g. Luminance at 30° and 45° in<br>diagonal, horizontal, and vertical<br>directions at center and four<br>corners | Angular dependency of luminance by AAPM-TG18 |
| h. Luminance uniformity or Mura<br>test | Luminance Uniformity by AAPM-TG18<br>Chromaticity by AAPM-TG18 |
| i. Stability of luminance and<br>chromaticity response with<br>temperature and time of operation<br>or on-time | 0°C, 25°C, and 40°C on Luminance response by<br>AAPM-TG18<br>(Power On Drift.) |
| j. Spatial noise | Noise Power Spectrum |
| k. Reflection coefficient | Specular reflection and Diffuse reflection by<br>AAPM-TG18 |
| I. Veiling glare or small-spot<br>contrast | Veiling Glare test by AAPM-TG18 |
| Other | Pixel fill factor<br>(Pixel structure and aperture ratio of pixel. |