21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)

K063197 · Totoku Electric Co., Ltd. · LLZ · Nov 30, 2006 · Radiology

Device Facts

• Record ID: K063197
• Device Name: 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Nov 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

Device Story

MDL2118A (ME355i2) is a 21.3-inch monochrome LCD monitor; accepts DVI video signals; provides UXGA (2048 x 1536) resolution. Used in clinical settings by trained medical practitioners for viewing diagnostic medical images. Features a newly developed luminance equalizer to maintain display consistency. Output is a visual representation of medical image data for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

21.3-inch monochrome LCD monitor; UXGA (2048 x 1536) resolution; DVI video input; includes luminance equalizer.

Indications for Use

Indicated for display and viewing of medical images for diagnostic purposes by trained medical practitioners. Not indicated for digital mammography.

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

• MDL2110A (K050485)

Submission Summary (Full Text)

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## 510(k) SUMMARY

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

Date Prepared: October 17, 2006

- 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) Device Name:
- Common Name: MDL2118A, ME355i2, 3M Monitor/Display
- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: MDL2110A (K050485)
- Device Description: MDL2118A (ME355i2) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (2048 x 1536) resolution for both landscape and portrait display.
- Indended Use: 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
- Substantial Equivalence: MDL2118A (ME355i2) shares the same characteristics with our predicate device MDL2110A (K050485) except for the newlydeveloped luminance equalizer.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NOV 3 0 2006

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

Re: K063197

K063197
Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2006 Received: October 20, 2006

Dear Mr. Hasegawa:

We have reviewed your Section 510(k) premarket notification of intent to market the device n & no reviewed your over of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass baced in also environd date of the Medical Device Amendments, or to devices that provision in the provision 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 I spice 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.

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Protecting and Promoting Public Health

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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/cdrl/industry/support/index.html.

Sincerely yours,

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

## 510(k) Number: Not Known

Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) Indications for Use:

21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for 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)

Nancy C Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063192

TOTOKU ELECTRIC CO., LTD.