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    syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·April 3, 2014

    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·January 12, 2007

    Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·October 14, 2010

    ENTrak Plus Navigation and Visualization System

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·July 12, 2004

    IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·December 24, 2008

    Sienet Cosmos. Radiological Image Processing. Model number 10018971

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·September 22, 2005

    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity" PACS infrastructure.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·September 25, 2008

    Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·August 22, 2008

    GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

    FDA Recall
    Terminated ·GE Medical Systems Information Technologies·Product code LLZ·July 18, 2005

    IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·May 14, 2007

    IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 5, 2011

    Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·April 2, 2007

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 27, 2012

    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 10, 2012

    InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·September 15, 2006

    GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·October 6, 2011

    Horizon Medical Imaging, Picture Archive Communication System (PACS).

    FDA Recall
    Terminated ·Mckesson Information Solutions LLC·Product code LLZ·December 23, 2013

    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

    Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

    Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·January 13, 2015