5M MEDICAL FLAT PANEL DISPLAY, ME511L

K031661 · Totoku Electric Co., Ltd. · LLZ · Apr 23, 2004 · Radiology

Device Facts

• Record ID: K031661
• Device Name: 5M MEDICAL FLAT PANEL DISPLAY, ME511L
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

ME511L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

Device Story

ME511L is a monochrome LCD medical display; used with Picture Archiving Communication Systems (PACS) for medical imaging. Operated by physicians in clinical environments to view diagnostic images. Device transforms digital image data from PACS into visual output on the LCD screen; assists physicians in clinical decision-making by providing high-resolution visualization of medical images.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monochrome LCD display (Model MDL2105A). Complies with medical safety standards UL2601-1, CSA No. 601-1, and EN60601-1. Complies with EMC standards FCC-A and EN60601-1-2.

Indications for Use

Indicated for use by physicians for medical imaging applications within Picture Archiving Communication Systems (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

• Totoku ME315L, 3 Megapixel Diagnostic Display (K030274)

Submission Summary (Full Text)

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APR 2 3 2004

# 510(k) Summary

as required by 807.92

Ko3/661

#### Company Identification 1.

Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN 011-81-268-34-5484 Tel: Fax: [phone]

#### Official Correspondent 2.

Mikio Hasegawa (Mr.) General Manager Product Development Dept.

#### Date of Submission 3.

May 26, 2003

#### Device Trade Name 4.

5M Medical Flat Panel Display, ME511L

#### Common Name 5.

Monitor, display, workstation, and others

#### 6. Classification

Classification
Medical display is classified as Class I or II per 21 CFR 899 2050

#### Predicate Device 7.

Totoku ME315L, 3 Megapixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K030274). Comparison of the principle characteristics of the device, which is pertinent to clinical performance, is shown in Appendix 1.

#### Description of Device 8.

ME511L is medical use display.

#### 9. Intended Use

ME511L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

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## 10. Explanation of ME511L

ME 511L is monochrome LCD display. ME511L (Model No. MDL2105A)

The specifications are shown in Appendix 2.

### 11. Compliance

ME511L complies with the following standards.

Medical Safety: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1),

and TUV-GM

MDD/CE (EN60601-1-2), FCC-A EMC:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle's body is composed of three vertical lines, and its legs are represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 2 3 2004

Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., LTD, MM Company, Design Group 300 Oya, Ueda, Nagano 386-1092 JAPAN

Re: K031661 Trade/Device Name: 5M Medical Flat Panel Display, ME511L Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: February 3, 2004 Received: February 5, 2004

Dear Mr. Hasegawa:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stared in the enot 28, 1976, the enactment date of the Medical Device Amendments, or to econiner of the they are reclassified in accordance with the provisions of the Federal Food, Drug, de noos that hat ( 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 I ou may, the cerony in 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 cquivalence determination does not mean I loase ve activities made a determination that your device complies with other requirements of the Act that 1 DA has made a very regulations administered by other Federal agencies. You must comply or any I bactar starss and 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your artist equivalence of your device to a legally premarket notification. The PDA intellig of substantial equivalians of 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
rs the regulation and 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - reg 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 Additionally, for questions on the promotive and any and on the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note their - Other gene Office of Compliatice at [phone]. This, production of the Peneral by reference to premarket nomication (210) it it all one of on the Division of Small
information on your responsibilities under the Act may be of the sumber [phone] information on your responsibilities under the Assistance at its toll-dreamenting html Manufacturers, International and Collisation Postedwith Art Collection of School

Sincerely yours,

Nancy C. Brogdon

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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Not known 510(k) Number (If known):

K63/661

5M Medical Flat Panel Display, ME511L Devicc Name:

Indications for Use:

ME511L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY

### Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR Over-The-Counter Use

David A. Lynam

(Optional Format 1-2-96)

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