19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A

K080951 · Totoku Electric Co., Ltd. · LLZ · May 29, 2008 · Radiology

Device Facts

• Record ID: K080951
• Device Name: 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

19-inch (48cm) 1.3M Color LCD Monitor CDL1909A is intended 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

19-inch 1.3M color LCD monitor; displays medical images for diagnostic review by trained medical practitioners. Device supports multi-scanning resolutions from VGA (640x400) to SXGA (1280x1024); compliant with VESA display standards. Used in clinical environments; provides visual output for physician interpretation of diagnostic images. Benefits include high-resolution visualization of medical data to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

19-inch 1.3M color LCD monitor; supports resolutions from 640x400 to 1280x1024; VESA standard display mode compliant.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for diagnostic purposes. 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

• 19-inch (48 cm) 1.3M Color LCD Monitor CDL1904A (K051403)

Submission Summary (Full Text)

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K080951

MAY 2 9 2008

# 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: March 17, 2008

Device Name: 19-inch (48 cm) 1.3M Color LCD Monitor CDL1909A

Common Name: CDL1909A

- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: 19-inch (48 cm) 1.3M Color LCD Monitor CDL1904A (K051403)
- Device Description: CDL1909A is a 19-inch (48cm) 1.3M Color LCD monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.
- Indended Use: 19-inch (48cm) 1.3M Color LCD Monitor CDL1909A is intended 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.
- CDL1909A shares the same characteristics with our predicate Substantial Equivalence: device CDL1904A (K051403) except for frame, cover, rear cover, inverter board and power supply.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 2 9 2008

Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN

Re: K080951

Trade/Device Name: 19-inch (48 cm) 1.3M Color LCD Monitor CDL1909A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 17, 2008 Received: April 3, 2008

#### 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 (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.

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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 et 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, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Leportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max obtain other general information on your responsibilities under the Act from the Division of Styall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html .

Sincerely vours.

Nancy 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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## INDICATIONS FOR USE

510(k) Number: Not Known - 0 80 9 51 Device Name: 19-inch (48 cm) 1.3M Color LCD Monitor CDL1909A Indications for Use:

19-inch (48 cm) 1.3M Color LCD Monitor CDL1909A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

Prescription Use _ U (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)

Rogui M. Whan

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