Efilm Lite

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EFilm (eFilm.exe). EFilm is an application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US units, computed and digital radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed.

  • Efilm Lite Software Listing (Page3). AlphaControls Lite Edition is a package of standard and unique skinable VCL's for professional UI design development using 'AlphaSkins'. The K-Lite Codec Pack is a collection of DirectShow filters, VFW/ACM codecs, and tools.
  • Download efilm lite viewer for free. Photo & Graphics tools downloads - eFilm Workstation by Merge Healthcare and many more programs are available for instant and free download.

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Class 2 Device Recall eFilm Workstation
Date Initiated by FirmOctober 20, 2016
Create DateDecember 05, 2016
Recall Status1Terminated 3 on May 30, 2019
Z-0707-2017
Recall Event ID75270
K020995
System, image processing, radiological - Product CodeLLZ
ProductMerge, eFilm Workstation and eFilm Lite
eFilm Workstation with Modules is a software application that is used for viewing 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 Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians
Code InformationEFilm 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.
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .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.
Software design
Merge Healthcare sent an Urgent Medical Device Recall letter dated October 12, 2016, to all affected consignees. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Actions by Merge, and Actions by Customers. Advised consignees to discontinue using the product, and identify & notify all customers. Requested consignees for a response to the notification. Customers with questions were instructed to send an email to recall@merge.com.
2163
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.
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ and Original Applicant = EFILM MEDICAL, INC.

What eFilm Workstation can do for you

eFilm Workstation®, part of IBM Watson Health™, is a stand-alone workstation solution to view, distribute and manage studies. You get a full diagnostic quality workstation with dedicated CD/DVD burning, DICOM printing and an image review station that is scalable to any organization.

eFilm Workstation can supplement your current PACS workflow or serve as a main workstation. An FDA Class II registered device, it has many tools including image management and distribution with DICOM Query/Retrieve, CD/DVD burning and auto-routing of studies. It is a primary diagnostic viewer with hanging protocols, key images, SUVs for PET/CT, MIP, MPR and more.

Stores and distributes DICOM studies

eFilm provides the capability to allow routing of studies based upon flexible rules that are managed within eFilm.

Supports all imaging modalities

eFilm workstation is a complete imaging and diagnostic workstation.

Acts as a hub

It allows you to centralize the auto-routing of studies to other eFilm installations or PACS.

Offers image compression

eFilm workstation lets you get around bandwidth constraints by simply compressing and then sending files.

Supports Gray Scale Presentation State

GSPS images will be displayed using industry-standard GSPS instead of the former proprietary format.

Six good reasons to use eFilm Workstation

  • Ensure quality care
  • Easily manipulate images
  • Achieve greater user security
  • Manipulate images in a variety of ways
  • Integrate CD and DVD creation
  • Gain a variety of user-friendly features

Award winning VNA for storing DICOM and non-DICOM images, from disparate PACS, specialties and sites

Simplifies clinical workflows and enables IT organizations to scale their delivery of care

Assists clinical decisions by extracting patient information from the EHR and projecting it with PACS

Your single-source solution to simplify the process of deploying imaging AI applications

This suite of solutions is designed to meet the needs of orthopedic practices and surgeons for image management

EfilmEfilm

Uses a retrospective AI-enabled data review tool to drive accurate, timely and coordinated care decisions

Efilm Lite Viewer Free Download

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Delivers MRI data visualization and analysis to streamline reporting and interventional planning

Helps healthcare providers manage IT infrastructure through an all-in-one RIS-PACS-reporting platform

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eFilm Workstation and eFilm Enterprise Solutions are scalable and cost-effective for diagnostic viewing needs

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A radiology system that successfully stores, manages and distributes patient radiology information