FLAT PANEL DISPLAY, ME183L

{0}------------------------------------------------ K030272 # 510(k) Summary as required by 807.92 ### Company Identification 1. Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN Tel: 011-81-268-34-5484 Fax: 011-82-268-34-5565 ### 2. Official Correspondent Mikio Hasegawa (Mr.) General Manager Product Development Dept. - Date of Submission 3. Jan. 24, 2003 - Device Trade Name 4. Flat Panel Display, ME183L ### Common Name 5. Monitor, display, workstation, and others ### 6. Classification Medical display is classified as Class I or II per 21 CFR 890.2050 ### 7. Predicate Device Totoku ME311L 3 Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principle characteristics of the one device which is pertinent to clinical performance is shown in Appendix 1. ### Description of Device 8. ME183L is a display for medical use. ### 9. Intended Use ME183L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians. {1}------------------------------------------------ # 10. Explanation of ME183L ME 183L is a monochrome LCD display. ME183L (Model No. MDL1812A) Specifications are shown in Appendix 2. # 11. Compliance ME183L complies with the following standards. Medical Safety: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1, IEC60601-1), and TUV-GM EMC: MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-B and VCCI-B {2}------------------------------------------------ | vice<br>e<br>)<br>f | |--------------------------------------------------| | te<br>Jat<br>t<br>Prec | | with<br>Jhart | | (<br>8%<br>9<br>SO | | ar<br>Jomp<br>1<br>4 | | 1<br>C<br>ificat.<br>reci.<br>8%.<br>1<br>œ<br>C | | <br><br>ﺮ<br>er<br>1<br>6<br>ﻠ<br>1<br>1 | - . , | Item | ME311L | ME183L | Item | | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K012099 | Not known | 510(k) Number | ME183L | | Display area | Horizontal:423.9mm, Vertical:318.0mm | Horizontal: 359.0mm, Vertical: 287.2mm | Display area | Not known<br>Horizontal: 359.0mm, Vertical: 287.2mm | | Input signal | GVIF video signal<br>10214-1210VE (3M:MDR14P) | D-SUB(analog), BNC,<br>NTSC/PAL(Y/Cb/Cr), s-Video | Input signal | D-SUB(analog), BNC,<br>NTSC/PAL(Y/Cb/Cr), s-Video | | Maximum display pixels | Portrait: 1536 dots X 2048 line<br>Landscape: 2048 dots X 1536 line | 1280 X 1024 dots | Maximum display pixels | 1280 X 1024 dots | | Scanning frequency | Horizontal:93KHz, Vertical:60Hz | Horizontal: 30K - 91KHz, Vertical: 50 - 85Hz | Scanning frequency | Horizontal: 30K - 91KHz, Vertical: 50 - 85Hz | | Maximum image clock | 65MHz | 140MHz | Maximum image clock | 140MHz | | Maximum brightness | 600cd/m2 | 700cd/m2 | Maximum brightness | 700cd/m2 | | Brightness calibration | Software(option) | Software(option item) | Brightness calibration | Software(option item)<br>Photosensor(option item)-DTP92(X-Lite) | | Serial communication connector | Photosensor(option item)-DTP92(X-Lite)<br>D-sub 9P x 2 | Photosensor(option item)-DTP92(X-Lite)<br>D-SUB 15 x 1 | Serial communication connector | D-SUB 15 x 1 | | Agency standards | Medical safety:UL2601-1,CSA No.601-1<br>EN60601-1 | Medical safety: UL2601-1,CSA CSA C22.2 No.601.1<br>TUV-GM, FCC Class B, MDD/CE(EN60601-1,<br>EN60601-1-2), VCCI-B | Agency standards | Medical safety: UL2601-1,CSA CSA C22.2No.601.1<br>TUV-GM. FCC Class B, MDD/CE(EN60601-1,<br>EN60601-1-2), VCCI-B | | Dimensions and weight<br>(incl. Tilt and swivel) | MDD/CE:(EN60601-1, EN60601-1-2)<br>Net, 486x480x250mm(W x H x D) (landscape) 11kg<br>380x533x250mm(W x H x D) (portrait)<br>Packed, 733x642x363mm(W x H x D) 17kg | Net: 432x466x251mm(W x H x D) (landscape) 9.5kg<br>353x506x251mm(W x H x D) (portrait)<br>Packed: 470x670x340mm(W x H x D) 14kg | Dimensions and weight<br>(incl. Tilt and swivel) | Net: 432x466x251mm(W x H x D) (landscape) 9.5kg<br>353x506x251mm(W x H x D) (portrait)<br>Packed: 470x670x340mm(W x H x D) 14kg | | Power supply | 100-240V AC, 50/60Hz | Internal power supply 100-240V AC, 50/60Hz | Power supply | Internal power supply 100-240V AC 50/60Hz | {3}------------------------------------------------ # Appendix 2 Specifications of the Applied Model {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 5 2003 Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept., MM Company 300 Oya, Ueda-shi Nagano 286-0192 JAPAN Re: K030272 Trade/Device Name: Flat Panel Displav, ME183L Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 24, 2003 Received: January 27, 2003 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. {5}------------------------------------------------ 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 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 Page 2 {6}------------------------------------------------ K030272 510(k) Number (If known): Not known Flat Panel Display, ME183L Device Name: Indications for Use: ME183L 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 David A. Ryzwan (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number. L030772 OR Over-The-Counter Use (Optional Format 1 -2-96) Prescription Use