PHILIPS EASYVISION WORKSTATION

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font, positioned above a shield-like emblem. The emblem contains a circle with two wavy lines and two four-pointed stars inside it. Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is presented in a straightforward, unadorned manner, emphasizing its clarity and legibility. JAN 2 2 1998 ## Philips Medical Systems K974207 ## 510 (k) Summary of Safety and Effectiveness | Company Name: | Philips Medical Systems North America Company | |----------------------|--------------------------------------------------------------| | Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 | | Contact Person | Peter Altman | | Telephone Number: | 203-926-7031 | | Prepared (date): | October 31, 1997 | | Device Name: | Philips Easy Vision Family Workstation Option<br>EasyCorrect | | Classification Name: | Image Processing System<br>(90 LLZ) | | Common/Usual Name | Workstation | | Predicate Device | Easyvision Workstation | {1}------------------------------------------------ System Description: The EasyCorrect package is an option to the Vascular Analysis Package. EasyCorrect will support the creation of images acquired by a digital image intensifier based system that can be compared to conventional acquired images (cassette film). Thereby the same measurements can be performed on the digital acquired image as on the conventional acquired image. The EasyCorrect package will correct images for distortion through the following process: Calibration and clinical images are acquired according to acquisition protocols described in documentation delivered with the system. The calibration image will be acquired with a grid phantom included in the package. The software will compare the geometric characteristics of the calibration image (taken with the grid) with the actual geometrical characteristics of the grid. The difference(s) in geometrical characteristics between the two images is a measure of the distortion(s) in the digital acquired image. By applying the result of this calculation of distortion to clinical images taken under the same conditions as the calibration grid image, the clinical images can be corrected for the distortion(s) introduced by the digital technique. ## Intended Use: Easycorrect is intended for use in situations where digital images acquired from fluoroscopic imaging systems without distortion are required. The corrected images may be either hard-copy or soft-copy. Examples of (but not limited to) such situations are: making stereotactic measurements for Radiation Treatment Planning Systems or reconstructing digital spotfilm series into composite (survey) images. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 2 1998 Peter Altman Director of Regulatory Affairs Philips Medical Systems, Inc. North America Company 710 Bridgeport Avenue Shelton, CT 06484-0917 Re: K974207 EasyVision Workstation with Easy Correct Option Dated: November 7, 1997 Received: November 10, 1997 Regulatory class: Unclassified Procode: 90 LLZ 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 Food, Drug, and Cosmetic Act (Act). "You may, therefore, 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 either 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 requirement, as set forth in the Quality System Regulation (QS) 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 marked 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 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.fda.gov/cdrh/dsmamain.html". Sincerely yours. h7liau Yu 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 {3}------------------------------------------------ 510(k) Number (if known): Unknown K974-207 Philips Easy Vision Workstation Easy Correct Option Device Name : Indications For Use : EasyCorrect is intended for use in situations where digital images acquired from fluoroscopic imaging systems are desired or required without distortion. The corrected images may be either hard-copy or soft-copy. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Grand le. Leggon (Division Sign-Off) Abdominal, EN Division of Reproductive, and Radiological Dev 510(k) Number K974207 Prescription Use ( Per 21 CFR 801.109 OR Over-The-Counter Use (Optional Format 1-2-96)