BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·January 5, 2011

    Integrity R1.2

    FDA Enforcement
    Class II ·Terminated·Elekta Limited·March 7, 2018

    Agility with Integrity R3.2

    FDA Enforcement
    Class II ·Terminated·Elekta Limited·March 7, 2018

    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

    FDA Enforcement
    Class II ·Terminated·Elekta Limited·April 17, 2019

    Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

    FDA Enforcement
    Class II ·Terminated·Elekta Limited·May 15, 2019

    Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571

    FDA Enforcement
    Class II ·Terminated·Elekta Limited·June 17, 2020

    Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·October 1, 2005

    Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·August 23, 2007

    ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·December 1, 2017

    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·September 18, 2012

    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·December 9, 2015

    Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·November 21, 2008

    SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA. Used to facilitate the delivery of defined radiotherapy treatment plans.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·February 14, 2008

    Integrity R1.2

    FDA Recall
    Terminated ·Elekta Limited Fleming Way Crawley United Kingdom·Product code IYE·November 20, 2017

    Agility with Integrity R3.2

    FDA Recall
    Terminated ·Elekta Limited Fleming Way Crawley United Kingdom·Product code IYE·November 20, 2017

    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

    FDA Recall
    Terminated ·Elekta Limited Linac House Fleming Way Crawley United Kingdom·Product code IYE·March 12, 2019

    Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

    FDA Recall
    Terminated ·Elekta Limited Linac House Fleming Way Crawley United Kingdom·Product code IYE·April 3, 2019

    Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571

    FDA Recall
    Terminated ·Elekta Limited Linac House Fleming Way Crawley United Kingdom·Product code IYE·May 21, 2020