21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)

K113443 · Totoku Electric Co., Ltd. · LLZ · Dec 23, 2011 · Radiology

Device Facts

• Record ID: K113443
• Device Name: 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor, MS23i2 (ML21023) 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

21.3-inch monochrome LCD monitor; displays medical images for diagnostic review by trained medical practitioners. Inputs via DVI or Display Port interfaces. Device functions as a visual display unit for PACS or similar imaging systems. Used in clinical settings; operated by physicians or radiologists. Output provides high-resolution grayscale visualization of medical images to support clinical diagnostic decision-making. Benefits include accurate visual representation of diagnostic data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

21.3-inch monochrome LCD monitor; 1200 x 1600 (landscape) or 1600 x 1200 (portrait) resolution; DVI and Display Port connectivity. Class II device (21 CFR 892.2050).

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

• 21.3 inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A) (K081945)

Submission Summary (Full Text)

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## K113443

## TOTOKU

DEC 2 3 2011

## 510(k) SUMMARY

| Submitted Information: | TOTOKU ELECTRIC CO., LTD.<br>300 Oya, Ueda<br>Nagano 386-0192 Japan |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | November 18, 2011 |
| Device Name: | 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023) |
| Common Name: | MS23i2, ML21023 |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A)<br>(K081945) |
| Device Description: | MS23i2 (ML21023) is a 21.3-inch (54 cm) Monochrome LCD<br>monitor whose display resolution is 1200 x 1600 (landscape), 1600<br>x 1200 (portrait) supporting DVI (digital visual interface) and<br>Display Port. |
| Intended Use: | 21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor, MS23i2<br>(ML21023) is intended to be used in displaying and viewing<br>medical images for diagnosis by trained medical practitioners. It is<br>not meant to be used for digital mammography. |
| Substantial Equivalence: | MS23i2 (ML21023) shares the same characteristics with our<br>predicate device MS21i2 (K081945) except for the main board and<br>power supply. |

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is a prominent symbol, representing the federal government, and the text clearly identifies the department.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DEC 2 3 2011

Mr. Tsukasa Tashiro General Manager TOTOKU Electric Co., Ltd. 300 Ova 386-0192 UEDA NAGANO JAPAN

Re: K113443

Trade/Device Name: 21.3 inch (54cm) Monochrome LCD Monitor MS23i2 (ML21023) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 18, 2011 Received: November 21, 2011

Dear Mr. Tashiro:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number: Net-known 仁川口 443

Device Name: 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023)

Indications for Use:

21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) is intended 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.

Image /page/3/Picture/5 description: The image shows the words "Prescription Use" on the left side of the image. To the right of the words is a check mark above a line. The check mark indicates that the prescription use option has been selected.

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

ation and Safety office of in

510K k113443

TOTOKU ELECTRIC CO., LTD. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 Japan