5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)

K160326 · Jvckenwood Corporation · PGY · Feb 23, 2016 · Radiology

Device Facts

• Record ID: K160326
• Device Name: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
• Applicant: Jvckenwood Corporation
• Product Code: PGY · Radiology
• Decision Date: Feb 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis

Device Story

The MS55i2 and CCL550i2 are 21.3-inch LCD monitors designed for medical imaging. The MS55i2 is a monochrome display, while the CCL550i2 is a color display. Both support 5MP resolution (2048 x 2560) and connect via DVI or DisplayPort. They are used in clinical environments, specifically for digital mammography PACS, FFDM, and breast tomosynthesis. The monitors feature built-in front sensors and ambient light sensors to maintain brightness stability and image quality. They are operated by trained medical practitioners to view diagnostic images. The devices utilize a digital uniformity correction system to ensure consistent luminance and chromaticity across the display. By providing high-resolution, calibrated medical images, these monitors assist clinicians in accurate diagnostic interpretation, potentially improving patient outcomes in breast imaging.

Clinical Evidence

Bench testing only. The monitors were evaluated against AAPM-TG18 4.3 'Luminance Response' standards to ensure diagnostic image quality. No clinical studies were performed.

Technological Characteristics

21.3-inch TFT LCD (IPS) panels; LED backlighting; 5MP resolution (2048 x 2560); DVI and DisplayPort connectivity; built-in front and ambient light sensors; digital uniformity correction system; 10-bit/8-bit grayscale support; power requirements AC 100-240V.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for diagnosis in digital mammography PACS, including FFDM and breast tomosynthesis.

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

• 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2016

JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN

Re: K160326

Trade/Device Name: 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) 5MP Color LCD Monitor CCL550i2 (CL21550) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 29, 2016 Received: February 5, 2016

Dear Mr. Tashiro:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ocks

Robert 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K160326
Device Name

5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) 5MP Color LCD Monitor CCL550i2 (CL21550)

Indications for Use (Describe)

5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and

5MP Color LCD Monitor CCL550i2 (CL21550)

are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis

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)

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# 510(k) SUMMARY

| Submitted Information: | JVC KENWOOD Corporation<br>3-12, Moriya-cho, Kanagawa-ku,<br>Yokohama-shi, Kanagawa, 221-0022 Japan | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Tsukasa Tashiro, Engineering Specialist<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] | | |
| Date Prepared: | January 29, 2016 | | |
| Device Name: | 1. 5MP Monochrome LCD Monitor MS55i2<br>(ML21055, MD211G5)<br>2. 5MP Color LCD Monitor CCL550i2<br>(CL21550) | | |
| Common Name: | 1. MS55i2 (ML21055, MD211G5)<br>2. CCL550i2 (CL21550) | | |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) | | |
| Predicate Device: | 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) | | |
| Device Description: | MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome<br>LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color<br>LCD monitor. Their displays' resolution is 2048 x 2560 (landscape),<br>2560 x 2048 (portrait) supporting DVI (digital visual interface) and<br>DisplayPort. | | |
| Intended Use: | 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and<br>5MP Color LCD Monitor CCL550i2 (CL21550)<br>are intended to be used in displaying and viewing medical images<br>for diagnosis by trained medical practitioners.<br>They are to be used in digital mammography PACS, modalities<br>including FFDM, and breast tomosynthensis | | |

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Image /page/4/Picture/0 description: The image shows the JVC KENWOOD logo in dark blue. Below the logo is the text "creates excitement & peace of mind" in a lighter blue color. The logo is simple and modern, with a focus on the company's name and tagline.

# 510(k) SUMMARY

Substantial Equivalence:

### LCD Monitor MS55i2(ML21055, MD211G5)

| | EIZO RadiForce GX540 | LCD Monitor MS55i2<br>(ML21055, MD211G5) | Explanation of<br>Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K151883 | K131137 | JVC KENWOOD uses<br>typical data provided by the<br>panel<br>manufacturer.<br>For further explanation<br>refer to temporal response<br>of MS55i2. |
| Response Time<br>(typical) | 25ms (On/Off) | 25ms (On/Off) | |
| Resolution or<br>Matrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen<br>Technology | TFT Monochrome<br>LCD Panel (IPS) | TFT Monochrome<br>LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| Maximum<br>Luminance | Min.850cd/m²<br>Typ.1200cd/m². | Min.850cd/m²<br>Typ.1200cd/m². | - |
| DICOM<br>Calibrated<br>Luminance | 500cd/m² | 500cd/m² | - |
| Viewing Angle | CR>50<br>Horizontal: Typ.176<br>Vertical: Typ.176 | CR>50<br>Horizontal: Typ.176<br>Vertical: Typ.176 | - |
| 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.900 : 1<br>Typ.1200 : 1 | Min.900 : 1<br>Typ.1200 : 1 | - |
| Grayscale<br>Tones | 10-bit (DisplayPort): 1,024<br>from a palette of 16,369<br>tones<br>8-bit: 256 from a palette of<br>16,369 tones | 10-bit (DisplayPort): 1,024<br>from a palette of 12,277 tones<br>8-bit: 256 from a palette of<br>12,277 tones | Maximum bit depth by<br>Display port is 10 bit, it by<br>DVI is 8 bit.<br>Tone between the predicated<br>device and our monitors are<br>different. But our monitors<br>pass the exams in<br>AAPM-TG18 4.3<br>"Luminance Response".<br>Our monitors are equivalent<br>to the predicated device |
| Non-Uniformity<br>Compensation | Digital Uniformity<br>Equalizer (DUE) | Digital Uniformity correction<br>System | Our Uniformity<br>correction system is<br>equivalent to the<br>predicated device's one.<br>This system is helpful to<br>make visual performance<br>much better in the point<br>of luminance<br>(monochrome and color<br>version) and chromaticity. |
| Input Video Signal | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | - |
| Scanning<br>Frequency | 31 - 135 kHz / 24 - 61 Hz<br>Frame synchronous<br>mode: 24.5 - 25.5 Hz, 49<br>- 51 Hz | Portrait:<br>Horizontal:129.1KHz<br>Vertical:50Hz<br>Landscape:<br>Horizontal:103.5KHz | JVC KENWOOD specifies<br>only maximum scanning<br>frequency which is based on<br>the LCD panel driving<br>specification. |
| | | Vertical:50Hz | |
| Dot Clock | 290MHz | 285 MHz | JVC KENWOOD specifies<br>the dot clock which is based<br>on the LCD panel driving<br>specification. |
| | | | |
| Power<br>Requirements | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | AC100-240V, 50/60Hz | JVC KENWOOD<br>specification covers power<br>requirement specification of<br>the predicated device. |
| Power | 108 W | 80W | - |
| Consumption | Less than 0.7 W | Less than 2W | - |
| Power | DVI DMPM, | DVI DMPM, | - |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | - |
| | | | |
| QA Software | RadiCS | QA Medivisor / Medivisor NX<br>F-CAL | - |
| Sensor | Integrated Front Sensor<br>(IFS) | Built- in Front Sensor | - |
| | Backlight Sensor (BS) | None | Brightness stability is<br>controlled by the built-in<br>Front sensor. |
| | Ambient Light Sensor<br>(ALS) | Built-in ambient Light Sensor | - |
| | Presence Sensor (PS) | None | - |
| | | | |
| USB Ports /<br>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) | 388 x 496 x 99 mm | (AR, N) 474.5 x 390 x 98.1 mm<br>(F) 474.5 x 390 x 103.7 mm | - |
| | EIZO RadiForce GX540 | LCD Monitor CCL550i2<br>(CL21550) | Explanation of Differences |
| 510(k) Number | K151883 | K151007 | - |
| Response Time<br>(typical) | 25ms (On/Off) | 25ms (On/Off) | JVC KENWOOD uses typical data provided by the panel manufacturer.<br>For further explanation refer to temporal response of CCL550i2 |
| Resolution or<br>Matrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen<br>Technology | TFT Monochrome LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| Maximum<br>Luminance | Min.850cd/m2<br>Typ.1200cd/m2. | Min.700cd/m2<br>Typ. 1000cd/m2 | Maximum luminance of color model is lower than monochrome panel.<br>However DICOM Calibrated luminance is same as the predicated device. |
| DICOM<br>Calibrated<br>Luminance | 500cd/m2 | 500cd/m2 | Then actual performance for diagnosis is the same. |
| Viewing Angle | CR>50<br>Horizontal: Typ.176<br>Vertical: Typ.176 | CR>50<br>Horizontal: Typ.176<br>Vertical: Typ.176 | - |
| 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.900 : 1<br>Typ.1200 : 1 | Min.1000 : 1<br>Typ. 1300 : 1 | Contrast ratio of the color model is higher than the monochrome model. |
| Grayscale<br>Tones | 10-bit (DisplayPort): 1,024 from a palette of 16,369 tones<br>8-bit: 256 from a palette of 16,369 tones | 10-bit (DisplayPort): 1,024 from a palette of 65,473 tones<br>8-bit: 256 from a palette of 65,473 tones | Maximum bit depth by Display port is 10 bit, it by DVI is 8 bit.<br>Tone between the predicated device and our monitors are different. But our monitors pass the exams in AAPM-TG18 4.3 "Luminance Response".<br>Our monitors are equivalent to the predicated device |
| Non-Uniformity<br>Compensation | Digital Uniformity Equalizer (DUE) | Digital Uniformity correction System | Our Uniformity correction system is equivalent to the predicated device's one.<br>This system is helpful to make visual performance much better in the point of luminance (monochrome and color version) and chromaticity. |
| Input Video Signal | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | - |
| Scanning<br>Frequency | 31 - 135 kHz / 24 - 61 Hz<br>Frame synchronous mode: 24.5 - 25.5 Hz, 49 - 51 Hz | Portrait:<br>Horizontal: 129.1 KHz<br>Vertical: 50Hz<br>Landscape:<br>Horizontal: 103.5 KHz<br>Vertical: 50Hz | JVC KENWOOD specifies only maximum scanning frequency which is based on the LCD panel driving specification. |
| Dot Clock | 290MHz | 285 MHz | JVC KENWOOD specifies the dot clock which is based on the LCD panel driving specification. |
| Power<br>Requirements | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | AC100-240V, 50/60Hz | JVC KENWOOD<br>specification covers power<br>requirement specification of<br>the predicated device. |
| Power | 108 W | 95W | - |
| Consumption | Less than 0.7 W | Less than 2W | - |
| Power | DVI DMPM, | DVI DMPM, | - |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | - |
| QA Software | RadiCS | QA Medivisor / Medivisor NX<br>F-CAL | - |
| Sensor | Integrated Front Sensor<br>(IFS) | Built- in Front Sensor | - |
| | Backlight Sensor (BS) | None | Brightness stability is<br>controlled by the built-in<br>Front sensor. |
| | Ambient Light Sensor<br>(ALS) | Built-in ambient Light Sensor | - |
| | Presence Sensor (PS) | None | - |
| USB Ports / | 1 upstream, | 1 upstream, | - |
| Standard | 2 downstream / Rev. 2.0 | 2 downstream / Rev. 2.0 | - |
| Dimensions<br>w/o Stand<br>(W x H x D) | 388 x 496 x 99 mm | (AR, N) 474.5 x 390 x 98.1 mm<br>(F) 474.5 x 390 x 103.7 mm | - |

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MS55i2 adopts exactly the same panel as the predicated device, therefore its specification is completely same as the predicated device

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Maximum luminance of the CCL550i2-panel is low, but calibrated luminance at the time of factory shipment state is 500cd/m2.

This value is same as the predicated one. Moreover, contrast ratio of CCL550i2-panel is better, and other specifications in comparison items are similar. Therefore, our monitor is equivalent to the predicated device.

## JVC KENWOOD Corporation Professional & Healthcare Division

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