FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES

K021738 · Totoku Electric Co., Ltd. · LLZ · Aug 19, 2002 · Radiology

Device Facts

• Record ID: K021738
• Device Name: FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

Device Story

ME and CCL Series are medical-grade LCD flat panel displays; used by physicians to view medical images within PACS environments. Devices function as visual output interfaces for diagnostic workstations. ME series are monochrome; CCL series are color. Displays receive video signals from PACS workstations; provide high-resolution visualization of medical imaging data to support clinical interpretation and diagnostic decision-making.

Clinical Evidence

Bench testing only; compliance with medical safety (UL2601-1, IEC60601-1) and EMC standards (IEC60601-1-2) demonstrated.

Technological Characteristics

LCD flat panel displays; monochrome (ME series) and color (CCL series) models. Compliance with UL2601-1, CSA No. 601-1, IEC60601-1, and EN60601-1-2. Models include ME181L, ME201L, ME203L, CCL182, CCL202, and CCL314.

Indications for Use

Indicated for use by physicians for viewing medical images 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 ME311L 3Mega Pixel Diagnostic Display (K012099)

Submission Summary (Full Text)

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## 510(k) Summary

as required by 807.92

KU21738

#### 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 24, 2002

#### Device Trade Name 4.

Flat Panel Displays, ME Series and CCL Series

#### Common Name 5.

Monitor, display, workstation, and others

#### Classification 6.

Medical displays were classified in Class II per 21 CFR 890.2050

#### Predicate Device 7.

Totoku ME311L 3Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principal characteristics of the one device which is pertinent to clinical performance is shown in Appendix 1.

#### Description of Device 8.

The ME and CCL Series Medical Displays are displays for medical use.

#### Intended Use 9.

The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

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## 10. Explanation of ME Series and CCL Series

ME Series are monochrome LCD displays consists of the following models.

ME181L (Model No. MDL1809A)

ME201L (Model No. MDL2006A)

ME203L (Model No. MDL2004A)

CCL Series are color LCD displays consists of the following models.

CCL182 (Model No. CDL1808A)

CCL202 (Model No. CDL2005A)

CCL314 (Model No. CDL2103A)

Comparison of specifications are shown in Appendix 2.

## 11. Compliance standards

All ME Series are complies with following standards.

Medical Safety: UL2601-1, CSA No. 601-1, IEC60601-1 MDD/CE (EN60601-1)

- EMC: MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-B and VCCI-B for ME181L (MDL1809A) and ME201L (MDL2006A). MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-A and VCCI-A for ME203L (MDL2004A)
All CCL Series are complies with following standards.

ITESafety: UL1950, CSA No.950, LVD/CE(EN60950)

EMC/CE (EN55022, EN55024), FCC-B and VCCI-B EMC: for CCL182 (CDL1808A) and CCL202 (CDL2005A). EMC/CE (EN55022, EN55024),FCC-A and VCCI-A for CCL314 (CDL2103A).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 9 2002

Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept. MM Company 300 Oya, Ueda-Shi, Nagano 386-0192 JAPAN

Re: K021738

Trade/Device Name: Medical Flat Panel Displays, ME and CCL Series Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: May 24, 2002 Received: May 28, 2002

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. Iisting 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 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 (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 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:

| 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" (21 CFR Part 807.97). 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. 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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510(k) Number (If known): Not known

- K.021738

Flat Panel Display, ME and CCL Series Device Name:

Indications for Use:

The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians.

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### Concurrence of CDRH, Office of Device Evaluation

David A. Seymon

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

Prescription Use V

OR Over-The-Counter Use

(Optional Format 1-2-96)