114 results
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31ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
MOSAIQ Oncology Information System
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·June 17, 2026
Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·May 6, 2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·February 18, 2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·January 21, 2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·February 18, 2026
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·February 4, 2026
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·November 12, 2025
MOSAIQ Oncology Information System
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·February 19, 2025
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Enforcement
Class II
·Ongoing·Elekta Inc·March 15, 2023
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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