PHILIPS TOMOSCAN CS

{0}------------------------------------------------ 6 1008 Image /page/0/Picture/1 description: The image shows the Philips logo. The logo is in black and white and features the word "PHILIPS" at the top. Below the word is a shield-like shape containing a circle with wavy lines and four stars. The stars are positioned at the top left and bottom right of the circle. Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in large, bold, black letters. Below the word "PHILIPS", there is a handwritten alphanumeric string "K982631". The text and string are the main focus of the image. ## Philips Medical Systems July 24, 1998 # 510(K) Summary In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device. | CLASSIFICATION NAME: | Computed Tomography X-ray System (Class II; Tier 2; 90JAK, 21 CFR 892.1750) | |-------------------------|-----------------------------------------------------------------------------| | COMMON/USUAL NAME: | CT X-ray System | | TRADE/PROPRIETARY NAME: | Philips TOMOSCAN CS | | ESTABLISHMENT NO.: | 1217116 | | CONTACT PERSON: | Peter Altman, Director of Regulatory Affairs | #### SYSTEM DESCRIPTION: The TOMOSCAN CS is a whole body scanner based on slipring technology. With the TOMOSCAN CS, Philips introduces a new product to its TOMOSCAN product family which is based on and includes the technological features of existing computed tomography systems and support systems, i.e. Philips TOMOSCAN AVP1, TOMOSCAN EG, and Easy Vision Workstation. The TOMOSCAN CS is comprised of two main parts: - The operator console (back end part) to enable scanning and advanced image processing. It . is comprised of a data acquisition part and a post-processing part with separate monitors and keyboards for each part. - . The gantry and patient table (front end part). The gantry and table movements are controlled via the control panels on either side of the gantry. Patient positioning laser lights are mounted both externally on the gantry as an aid to patient positioning and at the scan plane. All scanning facilities and features of the TOMOSCAN CS are the same as with predicate devices TOMOSCAN AVP1 (previously named TOMOSCAN SR5000, ref: K944326) and TOMOSCAN EG (also named ANATOM 2000; ref: K964890). The viewing and image processing features of the predicate device EasyVision (ref: K920950) are integrated as part of the TOMOSCAN CS system. ### INTENDED USE: The TOMOSCAN CS is a whole body Computed Tomography (CT) system which is a diagnostic X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. It includes signal analysis and display equipment, patient and equipment supports, component parts and laccessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. It is used for the display, storage and analysis of digital diagnostic CT images. The TOMOSCAN CS is intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment. > Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: (203) 926-7674 Fax: (203) 929-6099 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a bold, sans-serif font, positioned above a shield-like emblem. The emblem features a globe-like shape with wavy lines across the middle and a cross-like pattern within the globe. The logo is black and white. #### SUBSTANTIAL EQUIVALENCE INFORMATION: The TOMOSCAN CS is considered substantially equivalent to the Philips TOMOSCAN AVP1 (previously named TOMOSCAN SR5000, ref: K944326) and TOMOSCAN EG (also named ANATOM 2000, ref: K964890) with respect to its scanning capabilities and it is considered substantially equivalent to the Philips EasyVision Workstation (ref: K920950) with respect to its viewing and post-processing features. Each predicate device has been cleared for commercial distribution via its referenced 510(k) submission. #### SAFETY INFORMATION: Computed tomography is a mature technology with which industry and users of experience. These devices must comply with the appropriate sections of the Radiation Control for Health and Safety Act. The Philips TOMOSCAN CS and its labeling complies with the applicable requirements of the Federal X-ray Performance standards 21CFR 1020.33. A Product Report according to 21 CFR 1002.10 will be submitted to FDA prior to the first delivery of the TOMOSCAN CS. The TOMOSCAN CS also complies with the international standard IEC-601-1. national safety standard UL-2601-1 and the ACR/NEMA DICOM Version 3 digital imaging communication standard. The results of the hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the "Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review". {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT C 1008 > Peter Altman Director of Regulatory Affairs Phillips Medical Systems 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917 Re: K982631 "Philips Tomoscan CS, CT Device Dated: July 24, 1998 Received: July 28, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK Dear Mr. Altman: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Pool, Drug, and Cosmetic Act (Act), "You may, therefore, market the device, subject to the general controls provisions of the Act The general controls 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 either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections; the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulators action. In addition, PDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 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) 638-2041 or (301) 443-6597 or at its-Internet address "http://www.fde:gov/oddfddsmaldsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The logo is black and white. {3}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name : ________________________________________________________________________________________________________________________________________________________________ Philips TOMOSCAN CS Indications For Use : The TOMOSCAN CS is a whole body Computed Tomography (CT) system which is a diagnostic X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. It includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. It is used for the display, storage and analysis of digital diagnostic CT images. The TOMOSCAN CS is intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (vision Sign-Off) Off Eision of Seo sion of Reproductive, Abdominal, ENT Radiological De 510(k) Number K982631 Prescription Use ( Per 21 CFR 801.109 ) Image /page/3/Picture/10 description: The image shows the letters "OR" with a circle around them. The letters are in a bold, sans-serif font. The image is slightly blurry and has some artifacts, suggesting it may be a scan or a low-resolution image. The background is white. Over-The-Counter Use (Optional Format 1-2-96)