QONTRAST

{0}------------------------------------------------ K040399 MAR 2 9 2004 510(k) Summary Amid. s.r.l. Qontrast ## 510(k) Summary The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a). 807.92(a)(1) ## Submitter Information | Colleen Densmore, Official Correspondent | | |------------------------------------------|---------------------------------------------| | The Anson Group | | | 7992 Castleway Drive | | | Indianapolis, Indiana 46250 | | | Phone: | (317) 849-1916 | | Facsimile: | (317) 577-9070 | | Contact Person: | Carri Graham | | Date: | February 16, 2004 | | 807.92(a)(2) | | | Trade Name: | Qontrast software | | Common Name: | Picture archiving and communications system | | Classification Name(s): | System, Image processing | | Classification Number: | LLZ - 892.2050 | | 807.92(a)(3) | | Predicate Device(s) | ATL d/b/a Philips Ultrasound | |------------------------------| | QLAB Software | | K021966 | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is facing right and is positioned above the text "DEPARTMENT OF HEALTH & HUMAN." The text is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAR 2 9 2004 AMID, s.r.l. % Ms. Carri Graham Consultant The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K040399 Trade/Device Name: Qontrast Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 13, 2004 Received: February 17, 2004 Dear Ms. Graham: 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 cither 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. 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, {2}------------------------------------------------ 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. Brygdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K040399 Qontrast Software Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data. Prescription Use X (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C Broodon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number. K040399 Page 1 of 1