This guide has been produced to assist in providing instruction for the Merge emed product suite.
EFILM LITE 2.1 MANUAL
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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EFILM LITE 2.1 CODE
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = LLZ and Original Applicant = EFILM MEDICAL, INC.2 efilm Lite 2.1 User Guide Version 1 Part number OctoCopyright notice Copyright 2005 Merge Technologies Inc W. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide Distribution - US: Nationwide including DC, GU, PR and Internationally to Canada, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.ġ A record in this database is created when a firm initiates a correction or removal action. Customers with questions were instructed to send an email to in Commerce Requested consignees for a response to the notification. Advised consignees to discontinue using the product, and identify & notify all customers. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Actions by Merge, and Actions by Customers. Merge Healthcare sent an Urgent Medical Device Recall letter dated October 12, 2016, to all affected consignees. cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing. cal (Calibration) is not displayed and measurement is not correct. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and cliniciansĮFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.Ī product issues happens for RF projection images. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. In addition, users can overlay templates on medical images to aid in preoperative planning. Users have access to various image processing and measurement tools to assist them in viewing images. eFilm Workstation with Modules can be used to communicate, process and display medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).
EFILM LITE 2.1 SOFTWARE
System, image processing, radiological - Product Code LLZĮFilm Workstation with Modules is a software application that is used for viewing medical images.
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