21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)

K131137 · Jvckenwood Corporation · LLZ · Jul 18, 2013 · Radiology

Device Facts

• Record ID: K131137
• Device Name: 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
• Applicant: Jvckenwood Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jul 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS55i2 (ML21055, MD211G5) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Device Story

MS55i2 is a 21.3-inch monochrome LCD monitor for digital mammography; displays medical images from PACS and FFDM modalities. Device utilizes sub-pixel driving techniques to independently drive 15M subpixels; supports DVI and DisplayPort inputs. Operated by trained medical practitioners in clinical settings. Device transforms digital input signals into high-resolution grayscale images; provides 10.3-bit grayscale (1276 gradations) via 11-bit LUT. Includes 'Mediviser' software for DICOM GSDF calibration and QC/QA. Output allows clinicians to view diagnostic-quality mammographic images; aids in clinical decision-making by providing high-contrast, high-resolution visualization of medical data.

Clinical Evidence

Bench testing only. Performance verified against AAPM-TG18 guidelines for luminance response, uniformity, geometric distortion, and chromaticity. No clinical data presented.

Technological Characteristics

21.3-inch monochrome AMLCD panel; 2048x2560 resolution; 10.3-bit grayscale (1276 steps) via 11-bit LUT. Connectivity: DVI, DisplayPort, USB. Luminance: 1200 cd/m2 (typ). Calibration: Mediviser software (DICOM GSDF). Safety standards: UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE.

Indications for Use

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

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 cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053) (K111496)

Submission Summary (Full Text)

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131137 2

## JVCKENWOOD

## JUL 1 8 2013

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# 510(k) SUMMARY

| Submitted Information: | JVC KENWOOD Corporation<br>3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi,<br>Kanagawa, 221-0022 Japan |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | July 17, 2013 |
| Device Name: | 21.3 inch Monochrome Digital Mammography LCD Monitor MS55i2<br>(ML21055, MD211G5) |
| Common Name: | MS55i2, ML21055, MD211G5 |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor<br>MS53i2 (ML21053) (K111496). |
| Device Description: | MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCD<br>monitor whose display resolution is 2048 x 2560 (landscape), 2560 x<br>2048 (portrait) supporting DVI (digital visual interface)<br>and<br>DisplayPort. |
| Intended Use: | 21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor<br>with sub-pixel driving techniques enabling 15M subpixels to be driven<br>independently, MS55i2 (ML21055, MD211G5) is intended to be used in<br>displaying and viewing medical images for diagnosis by trained medical<br>practitioners. It is to be used in digital mammography PACS and<br>modalities including FFDM. |
| Substantial Equivalence: | MS55i2 (ML21055, MD211G5) shares the same characteristics with our<br>predicate device MS53i2 (ML21053) (K111496) except for the main<br>board, LCD panel and power supply. |

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| 510(k) Number | 5M Monochrome Digital Mammography<br>LCD Monitor MS53i2 (ML21053) (K111496)<br>Conventional LCD Panel (IAQS80P) | 5M Monochrome Digital Mammography<br>LCD Monitor MS55i2 (ML21055, MD211G5)<br>New LCD Panel (TX54D84MM0BAA) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Area | K061447<br>Horizontal: 337.9mm, Vertical: 422.4mm | Not Known<br>Horizontal: 337.92mm, Vertical: 422.4mm |
| Input Signal | DVI, DisplayPort | DVI, DisplayPort |
| Maximum Display | 2048 x 2560 dots | 2048 x 2560 dots |
| Scanning Frequency | Horizontal: 129.6K, Vertical: 50Hz - Portrait<br>Horizontal: 103.93KHz, Vertical: 50Hz - Landscape | Horizontal: 129.6K, Vertical: 50Hz - Portrait<br>Horizontal: 103.5KHz, Vertical: 50Hz - Landscape |
| Maximum Image Clock | 148 MHz | 285 MHz |
| Maximum Luminance<br>(Calibrated Luminance) | Min.850 cd/m² Typ.1100cd/m²<br>(500 cd/m² - calibrated luminance) | Min.850 cd/m² Typ.1200cd/m² (as LCD component)<br>(500 cd/m² - calibrated luminance) |
| Contrast Ratio | Min.600 Typ.850 | Min.900 Typ. 1200 |
| Viewing Angle | CR>20 Typ.85deg | CR>50 Typ.176 horizontal/vertical |
| Luminance Calibration<br>(Optional) | Software (Standard): Medivisor<br>Calibration Sensor (Optional): Chroma5 (X-Rite) | Software (Standard): Medivisor<br>Calibration Sensor (Optional): Chroma5 (X-Rite) |
| Serial Communication | USB: Downstream port x 2, Upstream port x 1 | USB: Downstream port x 2, Upstream port x 1 |
| Grayscale | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) |
| Safety Standard | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE, | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE, |
| Weight & Dimension | Net: 12.1kg<br>474.5(W) x 480(H) x 220(D) mm (Landscape)<br>389(w) x 522(H) x 220(D) mm (Portrait)<br>Packed: 17.0 Kg<br>470(W) x 685 (H) x 345(D) | Net: approx. 12.8kg<br>474.5(W) x 480(H) x 220(D) mm (Landscape)<br>390(w) x 522(H) x 220(D) mm (Portrait)<br>Packed: approx.16.0 Kg<br>470(W) x 685 (H) x 345(D) |
| Power Supply | AC100-240V, 1.5-0.6A, 50/60Hz | AC100-240V, 1.5-0.6A, 50/60Hz |

Similarities :
MS55i2 (ML21055) employs the same diver board, tilt stand, power supply, etc. except of those of LCD Panel (included inverter board
Differences: Differences:

ellinentees.
MS55i2 (ML21055) employs a different LCD backlight) and the Maximum Luminance, contrast ratio and viewing angle have been
improved. MD211G5 is the same as MS55

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| Display System Description | | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 1. Active-Matrix Liquid-Crystal Displays (AMLCD) panel manufacturer, technology Screen size and<br>pixel pitch: | | |
| | Screen size: 422.4mm(H) x 337.92mm(V) at landscape display. 337.92mm(H) x 422.4mm(V) at<br>portrait display. Pixel pitch: 0.055mm(H) (sub-pixel pitch) x 0.165mm(V) at landscape display.<br>0.165mm(H) x 0.055mm(V) (sub-pixel pitch) at portrait display | |
| | • Communicating ports:<br>Serial communication: USB (upstream x1, downstream x2) | |
| 2. Graphics card and software | | |
| | • Digital-to-Analog converters: speed and precision:<br>Only Digital operation, Digital to Analog converters are not provided.<br>• Software included: calibration, QC/QA (procedures with required frequencies and action<br>limits): | |
| | Totoku's calibration software called "Mediviser" optimizes the display's performance using<br>DICOM GSDF gamma and luminance. Calibration is recommended quarterly.<br>• On-screen GUI: On-screen GUI is not provided.<br>• Panel user controls: power switch | |
| Technical Specification | | |
| 1. Measuring Equipment<br>Refer to List | | |
| 3. Luminance response | 2. Declared and actual (measured with test pattern in the screen) array size:<br>Declared array size (spec): 422.4mm(H) x 337.92mm(V)<br>Actual array size (measured): 422.35mm(H) x 337.95mm(V) | |
| • max and min achievable luminance: | [SPEC] Luminance Max (L.max)=1200cd/m2. Luminance Min (Lmin)= 0.5cd/m2 | |
| • max and min recommended (operational) luminance: | [SPEC] Luminance Max recommend: Lmax(r)=500cd/m2. Lmin(r)=0.8cd/m2 | |
| • intrinsic bit-depth of the panel: [SPEC] 8bit per each subpixel | | |
| | • true output bit-depth by performing visual test with gradient test pattern:<br>[SPEC] 10.3bit gray scale (1276 steps) achieved by 11bit LUT (Look-up Table) in the Display<br>hardware. | |
| | • intrinsic luminance response at 256 digital values:<br>[SPEC] dJND per dP<3.000, dJNDs/dP max error<2.000. | |
| | JNDs/dP RMS error<1.000 | |
| | Above spec is based on AAPM-TG18 Advanced Luminance Response. 4.3.5<br>Refer to actual luminance response data | |
| | • conformance to a grayscale function (i.e., DICOM GSDF) at 256 digital values and angular<br>dependence of such conformance: | |
| | [SPEC] Kσ within +- 10% deviation to DICOM GSDF based on AAPM-TG18<br>Luminance Response 4.3.4 | |
| | Refer to actual luminance response data including angular dependence (Digital Driving Level vs<br>Delta L, L.) | |
| | • angular dependency of luminance:<br>[SPEC] C*1 R*=175, K*=30% | |
| 4. Luminance uniformity | [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual luminance<br>uniformity data | |

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K131137
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### [SPEC] Less than 2.0% based on A.APM-TG18, Refer to actual Geometrical Disturtion data 6. Display reflectance · Bi-directional reflection distribution function, or · specular and diffuse coefficients (ISO13406-2 by TUV) . [SPEC] Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4 Refer to actual Reflectance Data 7. Noise · Pixel fill factor (fefxos ISO 13406-2) ISPEC | 30% Min. Refer to Data of Pixel fill factor. · RMS (image variance) and noise power spectrum (weiner spectrum) ISPI C'10.1 Max at 0.6Hz. 3Hz. 30Hz Jitter. Refer to actual data 8. Veiling glare ISPI.C [Glare Ratio (GR) == 400 GR (I b=I m) (1 -1 m based on A \PM-1618 4,7,4 Reter to actual veiling glare ratio data 9. Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 809% Lmax based on AAPM-7018 4.8.4 Refer to Chromaticity actual data 10. Artifacts · pixel dropouts including spatial distribution (ISO13406-2 by TUV): [SPEC] Class (pixel) II. Refer to table 3 on 3.4.13 ISO13406-2 · phase/clock issues flicker · miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no ringing, ghosting image sticking 11. Spatial resolution, spatial MTF DATA | Refer to actual MH data 12. Temporal response · Temporal MTF, or · rise and fall time constants for 5-95% and 40-60% transitions by { 'M(). |SPIC | Rise Time Tr. Full Time | f. Tr. 1 Fessons. Refer to actual data 13. Stability (possibly determined via temperature or time stress tests) by TUV · of luminance response, of temporal response, of described artifacts 18PEC] Ko within +2 10% deviation to DICOM (iSDF, based on AAPM-T(18 I uminance Response 4.3.4 via temperature stress 0 deg('. 25deg('. 40degC Refer to actual measured data

[fefxos = for example, following ... or similar]

5. Geometrical distortion

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Image /page/4/Picture/0 description: The image shows a circular logo with an emblem in the center. The emblem appears to be a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. Encircling the emblem is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA' in a circular arrangement around the emblem.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002

July 18, 2013

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

Rc: K131137

Trade/Device Name: 21.3 inch Monochrome Digital Mammography LCD Monitor MS5512 (ML21055, MD211G5)

Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 19, 2013 Received: April 23. 2013

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. Iisting 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 is 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 (2) 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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Page 2 - Mr. Tashiro

forth in the quality systems (QS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Smh.7)

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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## Indications for Use

K131137 510(k) Number (if known):

Device Name: 21.3 inch Monochrome Digital Mammography LCD Monitor MS55i2 (ML21055, MD211G5)

Indications for Use:

21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS55i2 (ML21055, MD211G5) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> 210(k) K131137

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