5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)

K061447 · Totoku Electric Co., Ltd. · LLZ · Jul 21, 2006 · Radiology

Device Facts

• Record ID: K061447
• Device Name: 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) 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

The MDL2116A (ME551i2) is a 21.3-inch, 5-megapixel monochrome LCD monitor designed for high-resolution medical imaging. It receives digital image data via DVI interface from PACS or FFDM modalities. The device features a newly developed front sensor for display calibration and monitoring. It is intended for use by radiologists and trained medical practitioners in clinical environments to view diagnostic images. The high-resolution display supports the visualization of fine details necessary for digital mammography, aiding clinicians in accurate diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

21.3-inch monochrome LCD monitor; 2048 x 2560 (QSXGA) resolution; DVI interface; includes integrated front sensor for calibration; power supply and board components.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for diagnostic purposes within digital mammography PACS 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

• 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) (K041737)

Submission Summary (Full Text)

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K061447

## TOTOKU

JUL 2 1 2006

## 510(k) SUMMARY

| Submitter Information: | TOTOKU ELECTRIC CO., LTD.<br>300 Oya, Ueda<br>Nagano 386-0192 Japan | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Mikio Hasegawa, General Manager<br>Email: [e-mail]<br>Tel:[phone]<br>Fax:[phone] | |
| Date Prepared: | May 23, 2006 | |
| Device Name: | 5M Monochrome Digital Mammography LCD Monitor MDL2116A<br>(ME551i2) | |
| Common Name: | MDL2116A, ME551i2 | |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 5M Monochrome Digital Mammography LCD Monitor ME511L<br>(MDL2105A) (K041737) | |
| Device Description: | MDL2116A (ME551i2) is a 21.3-inch 5 megapixel monochrome<br>LCD monitor whose display resolution is 2048 x 2560 (QSXGA),<br>supporting DVI (digital visual interface). | |
| Intended Use: | 5M Monochrome Digital Mammography LCD Monitor MDL2116A<br>(ME551i2) is intended to be used in displaying and viewing<br>medical images for diagnosis by trained medical practitioners. It is<br>to be used in digital mammography PACS and modalities including<br>FFDM. | |
| Substantial Equivalence: | MDL2116A (ME551i2) shares the same characteristics with our<br>predicate device ME511L (K041737) except for a board, power<br>supply, and newly-developed front sensor. | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Oya, Ueda Nagano 386-0192 JAPAN

JUL 21 2006

Re: K061447

Trade/Device Name: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 23, 2006 Received: May 25, 2006

## 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 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 (Premarket Approval), 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.

Image /page/1/Picture/10 description: The image shows a logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with text around the perimeter and the letters "FDA" in the center. Below the letters are the words "Centennial" and three stars. The text "coting Public" is also visible at the bottom of the image.

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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 (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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/industry/support/index.html.

Sincerely vours.

Nancy C. Hogdon

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

Kob 1447 510(k) Number: Not Known Device Name: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) Indications for Use:

5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) 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 & (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)

David A. Lippman

vision of Reproductive, Abdominal, and Radiological Devices 510(k) Number