The user should be aware of the limitations in the accuracy and correctness of the output data displayed on the screen, printed, or exported from efilm. Our authorized representative in the European Community is: Anton van Kimmenade Merge emed Spegelt CD Nuenen NetherlandsĤ Considerations prior to use The software is not intended to replace the skill and judgement of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software s functions, capabilities and limitations. efilm satisfies the requirements for bearing the CE mark on its labelling. The K number for this product is K Europe According to the guidelines stated in Directive 93/42/EEC of the European Community, efilm is a Class I Medical Device. United States of America A 510(k) premarket notification for efilm with Modules was submitted to the United States Food and Drug Administration on March 19, On April 12, 2002, efilm received USFDA clearance as a Class II Medical Device. This product possesses a Class 2 Medical Device Licence issued May 30, 2001, by the Therapeutic Products Programme of Health Canada. Canada efilm is licensed for sale and use in Canada. Any additional software products named in this document are claimed as trademarks or registered trademarks of their respective companies.ģ Regulatory notes Merge emed provides you with the following information regarding the regulatory status of efilm in Lite form. Trademarks Merge emed, efilm, Fusion efilm, efilm Lite, efilm Scan, and efilm Video are all registered trademarks of Merge Technologies Inc. The authors of Merge emed shall have neither liability nor responsibility to any person or entity with respect to any loss or damages in connection with or arising from the information contained in this guide. Every effort has been made to make the information in this guide as accurate as possible. This guide has been produced to assist in providing instruction for the Merge emed product suite. This manual shall not wholly or in part, in any form or by any means, electronic, mechanical, including photocopying, be reproduced or transmitted without the authorized, written consent of Merge emed.

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