5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)

K041737 · Totoku Electric Co., Ltd. · LLZ · Jul 13, 2004 · Radiology

Device Facts

• Record ID: K041737
• Device Name: 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

ME511L (MDL2105A) is intended for use with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.

Device Story

The ME511L (MDL2105A) is a 21.3-inch monochrome LCD monitor designed for high-resolution medical imaging. It accepts digital video input via DVI (Digital Visual Interface) from a PACS workstation. The device provides a display resolution of 2560x2048 (QSXGA) pixels. It is intended for use by physicians in clinical environments to view and interpret medical images, including digital mammography. By providing high-resolution, high-luminance visualization, the monitor assists clinicians in diagnostic decision-making. The device functions as a peripheral display component within a larger PACS infrastructure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

21.3-inch monochrome LCD monitor; 2560x2048 (QSXGA) resolution; DVI (Digital Visual Interface) connectivity; Class II medical device (21 CFR 892.2050).

Indications for Use

Indicated for use by physicians for viewing medical images, including digital mammography, within a Picture Archiving and Communication System (PACS).

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

• Barco MGD 521M Digital Mammography Display (K033859)

Submission Summary (Full Text)

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JUL 1 3 2004

## 510(k) SUMMARY K041737

- TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Naqano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: [e-mail] Tel: [phone] Fax: [phone]

Date Prepared: June 22, 2004

- 5M Monochrome Digital Mammography LCD Monitor ME511L Device Name: (MDL2105A)
- Common Name: ME511L, MDL2105A

Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)

- Barco MGD 521M Digital Mammography Display (K033859) Predicate Device:
- ME511L (MDL2105A) is a 21.3-inch 5 megapixcel monochrome Device Description: LCD display whose display resolution is 2560x2048 (QSXGA), supporting DVI (ditital visual interface).
- Indended Use: ME511L (MDL2105A) is intended for used with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.
- Substantial Equivalence: ME511L employs a different display system from Barco's MGD521M (K033859), but maximum resolution and luminance are the same.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2004

Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano, 386-0192 JAPAN

Re: K041737

Trade/Device Name: 5M Monochrome Digital Mammography LCD Monitor ME511L (MD2105A) Regulation Number: 21 CFR 892.2050 -Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: June 23, 2004 Received: June 28, 2004

Dear Mr. Hasegawa:

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 The The The The The The The The The The The The The The The The The The 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number:

Device Name: 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) Indications for Use:

ME511L (MDL2105A) is intended for use with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041737