MODIFIED M-IV MAMMOGRAPHY SYSTEM

{0}------------------------------------------------ Page 1 ## Safety and Effectiveness 510(k) Summary Section 5.0 - The Modified M-IV Mammography Systems have been designed for 1. classification to Underwriters Laboratories, Inc. (UL) to Standard 187. - The Modified M-IV Mammography Systems have been designed for 2. classification by Underwriters Laboratories, Inc. to Canadian Standards Association, CSA Standard C22,2 No. 114. - The Modified M-IV Mammography Systems have been designed for 3. certification to International Electrotechnical Commission Standard IEC-601-1 - The Modified M-IV Mammography Systems are tested and conform to the 4. Federal Performance Standards for Ionizing Radiation Emitting Products, defined in 21CFR 1000. - The American College of Radiology (ACR) in Reston, Virginia, conducts a રે. nationwide program that accredits providers of mammography services. To qualify for ACR accreditation, the mammography device at a provider site must meet ACR standards for image quality and operation within radiation dose limits. The Modified M-IV Mammography Systems have been designed to meet the requirements for ACR accreditation. - A comprehensive Operator's Manual provided with each system is user friendly 6. and comprehensive, thus ensuring safe and effective operation of the Modified M-IV Mammography Systems. This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA). {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 forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 1 2001 Mr. Roaida Rizkallah Regulatory Specialist Lorad, A Hologic Company 36 Apple Ridge Road DANBURY CT 06810 Re: K011987 Modified M-IV Mammography System Dated: June 22, 2001 Received: June 26, 2001 Regulatory Class: II 21 CFR 892.1710/Procode: 90 IZH Dear Mr. Rizkallah: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section JTQ(F) notifications for use stated in the enclosure) to legally marketed predicate devices device is substantially colurations 16, 1976, the enactment date of the Medical Device Amendments, or to devices marketed in meestale continetec provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recassified in accordance will the provisions of the Act. The general controls provisions of the Act include requirements for annual registration of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Premarket Approval) it may be subject 11 your device is classince (SC ubove pairs offecting your device can be found in the Code of Federal Regulations, to such additional controls. Existing major regulations areemination assumes compliance with the Current Cood Manufacturing I tue 21, Patis 600 to 693. A Subsamany equintion (QS) for Medical Devices: General regulation (21 CFF Part Practice requirentents, as set tour in the Quality Dystom togeneral (FDA) will verify such assumptions. Friday 620) and that, through periodic Q5 mispection. In addition, FDA may publish further announcements to comply with the Use in the Federal Register. Please note: this response to your premarket notification submission does not concerning your device in the Pockal Register. Trease nown response under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding THIS leder will allow you to ocgally 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 and additionally 809.10 for in vitin If you desire specific advice to your device of Compliance at (301) 594-4639. Additionally, for questions on the promotion undentising 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 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 (s) {2}------------------------------------------------ 510(k) Number (if known): Device Name: Modified M-IV Mammography System Intended Use: The Modified M-IV Mammography System is intended to produce radiographic images The Modifical M-1 v Wianinograpily of of or screening and diagnostic mammography. of the breast. Tits specific meetable as to reasons of images for initial examination for Screening mainmography inverves the production of magnified images for more thorough examination of areas of the breast determined suspicious mages for more morough oxamilasses in the sampression views, and the unrough sereoning manilies are ... . . . . production of images used by a physician in preparation for biopsy. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use 21 CFR 801.109 OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ David C. Lyon (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number 00 4