Mammography Color Display DP-M3010

K143718 · Canon, Inc. · PGY · Jan 22, 2015 · Radiology

Device Facts

• Record ID: K143718
• Device Name: Mammography Color Display DP-M3010
• Applicant: Canon, Inc.
• Product Code: PGY · Radiology
• Decision Date: Jan 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners.

Device Story

DP-M3010 is a 30-inch 10MP color LCD display for medical imaging; used by trained practitioners for review/analysis of digital mammography. Device inputs digital image data via DisplayPort; transforms inputs using internal processing for display. Features include 'hybrid view' (simultaneous monochrome DICOM and color non-DICOM display) and 'Contrast Enhancer' (darkens image background). Built-in front and ambient light sensors monitor display status and adjust luminance/gradation based on surrounding light. Quality Control software installed on a connected computer manages calibration, testing, and monitoring. Device provides high-resolution visual output to assist clinicians in diagnostic review. Used in clinical settings; provides stable, calibrated image quality to support accurate clinical decision-making.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence supported by bench testing per FDA guidance for display accessories for full-field digital mammography. Tests included luminance response, uniformity, geometrical distortion, reflections, contrast ratio, MTF, noise power spectrum, chromaticity, pixel defects, artifacts, temporal response, and stability. Electrical safety and EMC testing also conducted.

Technological Characteristics

30-inch 10MP (4096 x 2560) TFT Color LCD (IPS) panel; LED backlighting; 10-bit gradation; 500 cd/m² luminance. Connectivity via DisplayPort 1.1a. Includes front sensor, ambient light sensor, and backlight sensor. Software-based calibration and quality control. Anti-reflection screen surface. Dimensions: 707 x 465 x 106 mm (w/o stand).

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including digital mammography, for review and analysis.

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

• RadiForce RX840-MG (K120451)

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

Canon Inc. - Hiratsuka Development Center % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo, Bunkyo-ku, Tokyo, 113-0033 JAPAN

January 22, 2015

Re: K143718

Trade/Device Name: Mammography Color Display DP-M3010 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: December 19, 2014 Received: December 29, 2014

Dear Izumi Maruo:

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 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.

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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 A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

# K143718

Device Name DP-M3010

Indications for Use (Describe)

The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

# a. Owner/Company name, address CANON INC.- HIRATSUKA DEVELOPMENT CENTER 22-5, Tamura 9-chome, Hiratsuka-shi, Kanagawa 254-0013, Japan

" Contact person Masaki Tamura Project Manager 011- 81-463-54-2211 Phone: [phone] Fax: [e-mail] Email:

# b. Contact/Application Correspondent

Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan

Phone: [phone] Fax: [phone] Email: [e-mail]

# c. Date prepared

December 19, 2014

### d. Name of device

| Trade Name: | Mammography Color Display DP-M3010 |
|----------------------------|---------------------------------------------|
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | Picture archiving and communications system |
| Classification Regulation: | 21 CFR 892.2050 |
| Product Code: | PGY |

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# e. Predicate devices

The Mammography Color Display DP-M3010 (hereinafter the DP-M3010) is substantially equivalent to the following legally marketed device:

| 510(k) Number | Trade name |
|---------------|--------------------|
| K120451 | RadiForce RX840-MG |

The predicate device is hereinafter called "RadiForce (K120451)" in this application.

# f. Description of the device

The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis. The DP-M3010 is consisted of the DP-M3010 display and the application software including Quality Control and Display Configuration Software. For the DP-M3010 display, 30-inch 10MP color LCD panel is used. The resolution is 10.5 megapixel (4096 x 2560). The DP-M3010 display has following two functions;

- . The hybrid view function: Monochrome compliant with the DICOM part 14 standard and color with non-DICOM gamma images are displayed on one screen at the same time.
- · The Contrast Enhancer function: Darkening the background of images.

The DP-M3010 has the built-in front sensor for monitoring display status. Using this front sensor allows for automatic correction of differences between the display characteristics that may change over time and the target image quality of the display. Also, The DP-M3010 has the ambient light correction function, namely correcting the luminance and gradation according to surrounding light by using the built-in ambient light sensor.

The Quality Control is software to be installed in a computer which controls the DP-M3010 display. The Quality Control software executes the calibration, runs tests compliant with various testing standards, creates test result reports, and monitors the DP-M3010 display conditions. The Display Configuration Software is used to perform the display settings. It is possible to save settings of the DP-M3010 Display on the computer. It is also possible to manually edit the areas for the hybrid view function.

## g. Indications for Use

The DP-M3010 is intended to be used in displaying digital images, including digital mammography for review and analysis by trained medical practitioners.

## h. Statement of substantial equivalence

The DP-M3010 has the same intended use as the RadiForce (K120451) as shown in Table 6-1. Comparison Table of Technological Characteristics.

Regarding differences of technological features between the DP-M3010 and the RadiForce (K120451) in Table 6-1, the non-clinical testing demonstrates that those differences do not raise any new questions of safety or effectiveness (The summaries of the non-clinical testing are shown in next part in this section).

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Comparison Table of Technological Characteristics is shown below.

| Feature | DP-M3010 | RadiForce (K120451) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 892.2050 | 892.2050 |
| Intended Use | The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners. | The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners. |
| Display Performance /Specification | | |
| Screen technology | TFT Color LCD panel(IPS) | TFT Color LCD panel(IPS) |
| Screen surface | Anti-Reflection | Anti-Glare |
| Viewing angle<br>(Horizontal,<br>Vertical) | Horizontal:170°,<br>Vertical:170°<br>(CR > 50) | Horizontal:176°,<br>Vertical:176°<br>(CR > 10) |
| Active screen size | 645.12 x 403.2 mm | 817.1 x 430.9 mm |
| Resolution | 10.5 MP(4,096 x 2,560) | 8MP(4,096 x 2,160) |
| Aspect ratio | 16:10 | 17:9 |
| Pixel pitch | 0.1575 x 0.1575 mm | 0.1995 x 0.1995 mm |
| Maximum<br>luminance | 500 cd/m² | 700 cd/m² |
| DICOM calibrated<br>luminance | 500 cd/m² | 500 cd/m² |
| Contrast ratio | 1000:1 | 1000:1 |
| Backlighting | LED | LED |
| Gradation | 10 bit | 8 bit, 10 bit |
| Luminance<br>non-uniformity<br>compensation | Yes | Yes |
| Response speed | 20 ms (black-white-black) | 25 ms (black-white-black) |
| Video Signal Input | | |
| Input video signals | DisplayPort 1.1a x 4 | DVI-D(Dual Link) x2,<br>DisplayPort x 2 |
| Scanning<br>Frequency(V) | 59.922 - 60.317Hz | 29.5 - 61Hz |
| Dot Clock | 174.25MHz x4 | DVI-D: 310MHz<br>DisplayPort: 290MHz |
| Power Related Specifications | | |
| Power<br>Requirements | AC 100 - 240V : 50/60Hz | AC 100 - 120V, 200 - 240V :<br>50/60Hz |
| Power<br>Consumption<br>Save Mode | 325W / 2W | 350W / 6W |
| Power<br>Management | DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a |
| Miscellaneous Features/ Specifications | | |
| QC software | Yes | Yes |
| Sensors | Backlight Sensor, Front Sensor,<br>Ambient Light Sensor | Backlight Sensor, Integrated<br>Front Sensor, Presence Sensor,<br>Ambient Light Sensor |
| USB Ports /<br>Standard | 1 upstream, 2 downstream / Rev.<br>2.0 | 1 upstream, 2 downstream / Rev.<br>2.0 |
| Dimensions w/o<br>stand<br>(W x H x D) | 707 x 465 x 106 mm | 896 x 527 x 157 mm |
| Contrast Enhancer<br>(Darkening image<br>Background) | Yes | No |

Table 6-1. Comparison Table of Technological Characteristics

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The DP-M3010 has the "Contrast Enhancer" function which can be used to darken the background of images, however, the RadiForce (K120451) does not have this function. Canon concluded that this function does not raise any new questions of safety or effectiveness because of following reasons:

- The Contrast Enhancer darkens background only.
- · User can set on or off the Contrast Enhancer as if necessary.
- · Device performance was not affected whether the Contrast Enhancer was on or off in performance testing.

The DP-M3010 does not have the presence sensor which is included in the RadiForce (K120451). The sensor only detects the presence of the user. Therefore, the display performance for clinical situation is unaffected by the presence sensor.

Based on the above, all the differences between the DP-M3010 and the RadiForce (K120451) do not raise any new concern. Thus, the DP-M3010 is substantially equivalent to the RadiForce (K120451).

#### Non-Clinical Performance Summary i.

The following bench tests were performed on the DP-M3010. Those tests are recommended in "Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions''.

- Luminance response
- Luminance uniformity
- Geometrical distortion
- · Display reflections including specular, diffuse, and haze components
- Small-spot contrast ratio

DP-M3010 JUNE 25, 2014

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- Spatial resolution expressed as modulation transfer function (MTF)
- · Noise expressed as noise power spectrum (NPS)
- · Pixel aperture ratio
- Chromaticity measured at the center of the screen at 5%, 50%, and 95% of the maximum luminance
- Chromaticity uniformity
- Pixel defect/faults
- Artifacts
- Temporal response
- · Stability of luminance

Those test results showed that the display performance of the DP-M3010 is equivalent to that of the RadiForce (K120451).

In addition to those bench tests, electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2 tests were performed. Those test results indicate that the DP-M3010 does not raise concern.

No animal or clinical testing was performed on the DP-M3010.

#### Conclusion i.

The DP-M3010 and the RadiForce (K120451) have the same intended use and the TFT Color LCD panel (IPS) screen. However, there are some different technological characteristics. Non-clinical tests showed that the different technological characteristics do not raise safety and effectiveness concern. Therefore, Canon concluded that the DP-M3010 is substantially equivalent to the RadiForce (K120451).