BEUDAMED
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    VITREA CT BRAIN PERFUSION

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·September 24, 2015

    VITREA2

    FDA Adverse Event
    Other ·VITAL IMAGES, INC.·Product code LNX·March 18, 2003

    CARDIAC FUNCTIONAL ANALYSIS (CFA)

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·March 12, 2013

    CT BRAIN PERFUSION

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·March 8, 2013

    CT BRAIN PERFUSION

    FDA Adverse Event
    Other ·VITAL IMAGES, INC.·Product code LLZ·April 1, 2013

    INNERVIEWGI

    FDA Adverse Event
    Other ·VITAL IMAGES, INC.·Product code LNX·April 18, 2003

    VITREA 2

    FDA Adverse Event
    Other ·VITAL IMAGES, INC.·Product code LNX·April 18, 2003

    VITREA ENTERPRISE SUITE

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·November 3, 2011

    VITREACORE

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·September 12, 2013

    VITREA

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·February 13, 1998

    CT BRAIN PERFUSION (4D BRAIN PERFUSION)

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC·Product code LLZ·January 31, 2018

    Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·March 15, 2013

    VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·October 21, 2013

    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 8, 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

    Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 11, 2011

    Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·February 5, 2013

    Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·February 23, 2010

    Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·August 23, 2010

    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·August 13, 2012