BEUDAMED
    84 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 2013

    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 25, 2017

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 18, 2017

    Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 18, 2017

    iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·June 25, 2014

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 19, 2014

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

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·August 29, 2018

    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·June 5, 2013

    Focal SIM Planning of radiation therapy

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·July 18, 2012

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Synergy XVI Intended for radiation therapy treatment.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·June 25, 2014

    MOSAIQ, 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 Enforcement
    Class II ·Terminated·Elekta, Inc.·June 25, 2014

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 29, 2014

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 11, 2013

    Monaco Product Usage: Planning of radiation therapy

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·July 18, 2012

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013