MODALIXX

{0}------------------------------------------------ | 125<br>0.0<br>1<br>1<br>4<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------ | | | - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------|------| | NA<br>ব<br>ี<br>- | N C<br>17 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | HNOT | **** | K 110108 FDA CDRH DMC # JAN 1 4 2011 Received ﺭﮦ ﮨﮯ ﮨﮯ ﮨﮯ ﮨﺎﺗﺎ ﮨﺎ ﮨﺎ Image /page/0/Picture/4 description: The image contains two logos. The first logo on the left is the ISO certified 9001:2008 logo. The second logo on the right is the ESD certified S20.20-2007 logo. # 510 (K) Summary As required by 807.92(c) ## 1. Company Identification MAR 1 6 2011 Ampronix Inc. 15 Whatney, Irvine, Ca, 92618 Tel: (949) 273-8000 Fax: (949) 273-8022 ## 2. Establishment Registration Number 3002816145 ## 3. Submitter Nelson Fathollahi President and CEO ## 4. Official Correspondent Asal Namini Director of International Business Development Tel: (949) 273-8000 Fax: (949) 273-8022 #### 5. Date of Submission January 5, 2011 #### 6. Device Trade Name MODALIXX G202MP ## 7. Common Name LCD Monitor (Medical Equipment) ## 8. Device Classification Medical Displays are classified in Class II per 21 CFR 890.2050, Picture archiving and communication system. {1}------------------------------------------------ #### 9. Intended Use The MODALIXX G202MP display is intended for use by physicians and the medical industry for diagnostic imaging applications along with the Picture Archiving Communication System (PACS). The Modalixx G202MP is also intended as a direct replacement for ageing CRT medical monitors. #### 10. Predicate Device Manufacturer: Totoku Electric Co. Device Name: Grayscale LCD Monitor Model Name: Totoku ME201L/r 510(k) NO. : K021738 #### 11. Substantial Equivalence to Predicate Device Modalixx G202MP is substantially equivalent to Totoku ME201L/r (K021738). They are both 20.1", 2 Mega Pixel Gray scale Modality displays. The Modalixx G202MP has a higher contrast ratio 1500:1 compared to 1000:1 of the ME201L/r. The G202MP has a higher brightness as well to assist in a more accurate image in diagnostics by providing higher brightness and contrast ratios. The brightness improved to 1000 CD/M2 from 700 CD/M2 in the ME201L/r. Comparison of the principal characteristics of the device which is a predicate to clinical performance is shown in Appendix 1 (Comparison Table with Predicate Device). #### 12. Compliance Standards | Medical Safety: | CSA-C22.2 | |-----------------|----------------| | EMC: | UL 60601-1, CE | #### 13. Device Description Modalixx G202MP is a grayscale High Bright medical LCD solution for modality CRT monitor replacement. G202MP will Auto Sync to any legacy grayscale or color analog modality and up scales it to clear, sharp, and vivid high bright 2 mega pixel resolution to provide the best diagnostic medical imaging applications. Armed with a complete set of input options, G202MP is compatible to nearly all medical modality applications. Modalixx G202MP medical LCD is capable of accepting any combination of BNC connections, including single to 5 BNC, as well as D-SUB 15. At any resolution from 525- 1600 horizontal pixels, G202MP can accept from low line to high line video signals through BNCs or VGA (D-sub15) inputs. This attribute of the Modalixx G202MP can be utilized in different types of medical imaging and application modalities as a true CRT imaging replacement. 11 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's wings and body. The eagle is facing to the right. ## 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. Asal Namini Director of International Business Development Ampronix, Inc. 15 Whatney IRVINE CA 92618 MAR 1 6 201 Re: K110108 Trade/Device Name: Flat Panel LCD Monitor, Modalixx G202MP Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 5, 2011 Received: January 14, 2011 Dear Mr. Namini: 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 {3}------------------------------------------------ medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours. Mary S 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "Ampronix Imaging Technology". The logo features a stylized graphic to the left of the word "Ampronix", with the words "Imaging Technology" underneath. The font is sans-serif and the text is black. Image /page/4/Picture/1 description: The image contains two logos. The first logo on the left is an ISO certified logo, specifically 9001:2008. The second logo on the right is an ESD certified logo, specifically S20.20-2007. # FDA Indication for Use 510(k) Number: K110108 Device Name: Flat Panel LCD Monitor, Modalixx G202MP ## Indications for Use: The MODALIXX G202MP display is intended to be used in displaying and viewing digital images for review by trained medical practitioners before the digital images are sent to other diagnostic displays. Modalixx G202MP is not meant to be used for mammography applications. マ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mary S Pastel Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K110108 - Ampronix Inc. www.ampronix.com 15 Whatney Irvine, California 92618 Phone (949) 273-8000 Fax (949) 273-8020