21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)

K090947 · Totoku Electric Co., Ltd. · LLZ · Aug 16, 2010 · Radiology

Device Facts

• Record ID: K090947
• Device Name: 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS31i2 (MDL2128A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Device Story

21.3-inch monochrome LCD monitor; 1536 x 6144 (landscape) or 6144 x 1536 (portrait) resolution; utilizes sub-pixel driving techniques to independently drive 9M subpixels. Used in clinical settings for viewing medical images, specifically digital mammography and FFDM. Operated by trained medical practitioners (radiologists) to facilitate diagnostic decision-making. Device connects via DVI. Output provides high-resolution grayscale visualization of medical images to assist in clinical diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

21.3-inch monochrome LCD; 3M pixel native resolution; sub-pixel driving technology for 9M subpixel control; DVI connectivity; digital mammography display.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for diagnosis in digital mammography PACS and modalities including FFDM.

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

• ME551i2 (MDL2116A) (K061447)
• MS51i2 (MDL2123A) (K071794)

Submission Summary (Full Text)

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K096947
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## 510(k) SUMMARY

| Submitter Information: | TOTOKU ELECTRIC CO., LTD.<br>300 Oya, Ueda<br>Nagano 386-0192 Japan | AUG 1 6 2010 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mikio Hasegawa, General Manager<br>Email: [e-mail]<br>Tel:[phone]<br>Fax:[phone] | |
| Date Prepared: | April 3, 2009 | |
| Device Name: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor<br>MS31i2 (MDL2128A) | |
| Common Name: | MS31i2, MDL2128A | |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 5M Monochrome Digital Mammography LCD Monitor ME551i2<br>(MDL2116A) (K061447) and MS51i2 (MDL2123A) (K071794). | |
| Device Description: | MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD<br>monitor whose display resolution is 1536 x 6144 (landscape),<br>6144 x 1536 (portrait) supporting DVI (digital visual interface). | |
| Intended Use: | 21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD<br>Monitor with sub-pixel driving techniques enabling 9M subpixels<br>to be driven independently, MS31i2 (MDL2128A) is intended to<br>be used in displaying and viewing medical images for diagnosis<br>by trained medical practitioners. It is to be used in digital<br>mammography PACS and modalities including FFDM. | |
| Substantial Equivalence: | MS31i2 (MDL2128A) shares the same characteristics with our<br>predicate device ME551i2 (K061447) and MS51i2 (K071794) | |

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MS31i2 Premarket Notification

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

AUG 1 6 2010

Re: K090947

Trade/Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS31i2 (MDL2128A)

Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system

Regulatory Class: II.

Product Code: LLZ

Dated: June 25, 2010

Received: June 29, 2010

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 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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Enclosure

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,

Sincerely, yours,

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## INDICATIONS FOR USE

AUG 16 2010

510(k) Number: Not Known

Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS31i2 (MDL2128A)

Indications for Use:

21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

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)

*(Division Sign-Off)*

fice of Ir

K090947
-10K

TOTOKU ELECTRIC CO., LTD.