| 2026-02-18 | — | Brand Name: Leksell Gamma Knife
Product Description: Leksell Gamma Knife Perfexion
Leksell Gamma Kni | |
| 2025-12-14 | — | Brand Name: Elekta Medical Linear Accelerator
Product Name: Elekta Synergy, Elekta Harmony, Elekta I | |
| 2025-12-12 | — | Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Versi | |
| 2025-12-12 | — | Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Versi | |
| 2025-12-10 | — | MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) | |
| 2025-09-30 | — | Brand Name: Leksell Stereotactic System
Product Name: Leksell Vantage Stereotactic System
Software V | |
| 2025-01-15 | — | MOSAIQ Oncology Information System | |
| 2023-10-25 | — | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiati | |
| 2023-10-25 | — | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle | |
| 2023-10-25 | — | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerat | |
| 2023-10-25 | — | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy Sy | |
| 2023-10-25 | — | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accel | |
| 2023-10-25 | — | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation T | |
| 2023-05-05 | — | Elekta Medical Linear Accelerator (ELMA) included in the below platforms:
a. Elekta Infinity;
b. | |
| 2023-04-06 | — | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. | |
| 2023-02-28 | — | Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam | |
| 2022-12-05 | — | Oncentra Brachy radiation therapy planning system software. | |
| 2021-10-13 | — | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 | |
| 2021-09-17 | — | Elekta Medical Linear Accelerator (EMLA), configured as follows:
a. Elekta Precise Digital Accelera | |
| 2021-09-14 | — | Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for exte | |
| 2021-09-02 | — | MOSAIQ Oncology Information System | |
| 2021-07-26 | — | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 | |
| 2021-04-20 | — | Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted o | |
| 2020-04-30 | — | Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicate | |
| 2020-04-16 | — | Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco sy | |
| 2020-03-30 | — | Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neur | |
| 2019-12-18 | — | Elekta Unity, Image-Guided Radiation Therapy System | |
| 2019-11-22 | — | Monaco Radiation Treatment Planning System (RTP) System | |
| 2019-09-04 | — | Monaco RTP System, 5.40 Unity, radiation treatment planning system
Product Usage:
The Monaco system | |
| 2019-09-04 | — | Monaco RTP System, 5.50/5.51, radiation treatment planning system
Product Usage:
The Monaco system | |
| 2019-08-23 | — | Monaco Radiation Treatment Planning System (RTP) System | |
| 2019-07-03 | — | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System | |
| 2019-06-24 | — | Elekta Unity, Image-Guided Radiation Therapy System
Elekta Unity using Magnetic Resonance Imaging i | |
| 2019-06-19 | — | iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 | |
| 2019-02-08 | — | Monaco Radiation Treatment Planning (RTP) System | |
| 2018-12-13 | — | MOSAIQ Oncology Information System and Sequencer
MOSAIQ is an oncology information system used to m | |
| 2018-12-04 | — | MOSAIQ Oncology Information System Version 2.64.
MOSAIQ is an oncology information system used to | |
| 2018-08-03 | — | MOSAIQ Oncology Information System | |
| 2018-05-16 | — | HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT syste | |
| 2017-12-01 | — | ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platf | |
| 2017-09-01 | — | Elekta ERGO++
Product Usage:
ERGO is often used for stereotactic treatments. | |
| 2017-06-30 | — | MOSAIQ Medical Charged-Particle Radiation Therapy System | |
| 2017-06-21 | — | MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher
Product Usage:
MOSAIQ is an onco | |
| 2017-06-19 | — | iGUIDE Software 2.2
Product Usage:
Control of accurate patient positioning with assistance of a 30 | |
| 2017-05-23 | — | Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head struc | |
| 2017-01-10 | — | Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam r | |
| 2016-12-23 | — | Oncentra External Beam Oncentra Brachy
Product Usage:
Oncentra is radiation therapy planning softwa | |
| 2016-12-21 | — | Monaco RTP System
Product Usage:
Used to make treatment plans for patients with prescriptions for e | |
| 2016-12-02 | — | MOSAIQ Oncology Information System
The product is used to manage workflows for treatment planning | |
| 2016-11-17 | — | Monaco TRP System
The Monaco system is used to make treatment plans for patients with prescriptions | |
| 2016-11-03 | — | Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam ra | |
| 2016-09-29 | — | Monaco RTP System
The Monaco system is used to make treatment plans for patients with prescriptions | |
| 2016-08-18 | — | Monaco RTP System
Used to make treatment plans for patients with prescriptions for external beam ra | |
| 2016-08-18 | — | HexaPOD evo RT System
Product Usage:
The intended use of the device is the control of accurate pati | |
| 2016-07-15 | — | MOSAIQ Oncology Information System | |
| 2016-07-08 | — | Medical Linear Accelerator | |
| 2016-06-17 | — | MOSAIQ Oncology Information System | |
| 2016-05-18 | — | Monaco RTP System
Product Usage:
The Monaco system is used to make treatment plans for patients wit | |
| 2016-05-12 | — | iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy en | |
| 2016-04-19 | — | Radionuclide Radiation Therapy System
Product The product is a teletherapy device intended for ster | |
| 2015-12-18 | — | Oncentra External Beam - VMAT - Radiation therapy planning system
Product Usage: The Oncentra syst | |
| 2015-12-09 | — | MOSAIQ Oncology Information System
MOSAIQ is an oncology information system used to manage workflow | |
| 2015-11-24 | — | MOSAIQ Oncology Information System.
Used to manage workflows for treatment planning and delivery. | |
| 2015-10-16 | — | Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions | |
| 2015-09-15 | — | Monaco Radiation Treatment Planning System.
Used to make treatment plans for patients with prescrip | |
| 2015-08-31 | — | XiO Radiation Treatment Planning System.
Used to create treatment plans for any cancer patient for w | |
| 2015-07-01 | — | MOSAIQ Oncology Information System
MOSAIQ is an oncology information system used to manage workflows | |
| 2015-06-01 | — | Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell | |
| 2015-05-21 | — | Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatment | |
| 2015-01-29 | — | Elekta Precise Treatment Table | |
| 2015-01-07 | — | Precise Digital Accelerator
Intended to be used for radiation therapy treatments of malignant neopl | |
| 2014-12-19 | — | Focal Sim radiation therapy treatment planning system | |
| 2014-12-19 | — | Monaco radiation therapy treatment planning system.
The Monaco system is used to make treatment | |
| 2014-11-03 | — | MOSAIQ
Product Usage:
MOSAIQ is an oncology information system used to manage workflows for treatme | |
| 2014-10-06 | — | Laksell Gamma Knife Perfexion | |
| 2014-08-18 | — | Monaco
The Monaco system is used to make treatment plans for patients with prescriptions for exter | |
| 2014-08-18 | — | FOCAL Sim Workstation, Radiation Treatment Planning System.
Used for patient contouring and viewi | |
| 2014-05-29 | — | MOSAIQ
MOSAIQ is an oncology information system used to manage workflows for treatment planning and | |
| 2014-05-29 | — | iGUIDE System
Product Usage: The intended use of the device is the control of accurate patient pos | |
| 2014-05-23 | — | MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. | |
| 2014-04-23 | — | Synergy XVI
Intended for radiation therapy treatment. | |
| 2014-04-17 | — | HexaPOD evo RT Couchtop.
To support and aid in positioning a patient during radiation therapy. | |
| 2014-02-17 | — | XiO RPT System
The XiO RTP System is used to create treatment plans for any cancer patient for whom | |
| 2013-11-25 | — | Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the | |
| 2013-11-25 | — | Agility.
Version 3.0 of the Integrity interface and control software for the Elekta range of medical | |
| 2013-11-25 | — | Agility.
Version 3.1 of the Integrity interface and control software for the Elekta range of medical | |
| 2013-11-25 | — | XiO RTP System.
Used to create treatment plans for any cancer patient for whom external beam radiat | |
| 2013-11-25 | — | Synergy XVI
The Elekta Synergy S is intended to be used for radiation therapy treatment of malignan | |
| 2013-11-25 | — | Synergy XVI
XVI can incorrectly calculate the target position of the treatment table, because of an | |
| 2013-11-25 | — | XiO RTP System
The XiO RTP System is used to create treatment plans for any cancer patient for whom | |
| 2013-11-25 | — | Integrity.
Version 1.1 of the Integrity interface and control software for the Elekta range of medic | |
| 2013-11-25 | — | RT Desktop
The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to b | |
| 2013-08-15 | — | DMLC IV-ERGO - Beam shaping block for Radiation Therapy. | |
| 2013-07-23 | — | Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories
The device is part of t | |
| 2013-07-02 | — | Monaco RTP System
Radiation treatment planning | |
| 2013-05-28 | — | SL & SLi Series (Mod 15/18/20/25) Linear Accelerator
Used for radiation therapy treatments of malig | |
| 2013-05-28 | — | All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric | |
| 2013-05-22 | — | Monaco RTP System Radiation Therapy Treatment Planning System.
Radiation treatment planning. | |
| 2013-05-01 | — | DMLC IV-ERGO
Product Usage:
Intended for use with rotating gantry linear accelerators to conform ra | |
| 2013-04-30 | — | Integrity 3.0
Product Usage:
The Agility multileaf collimator is indicated for use when additional | |
| 2013-03-28 | — | Integrity 1.1.
Integrity is the interface and control software for the Elekta range of medical digi | |
| 2013-03-14 | — | Precise Treatment Table.
To be used as part of radiation therapy treatment process. | |
| 2013-02-11 | — | Monaco RTP System.
Radiation treatment planning. | |
| 2013-01-18 | — | Elekta, Apex add-on Micro MLC, collimator for radiation therapy. | |
| 2012-12-19 | — | Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1
Use | |
| 2012-09-18 | — | MOSAIQ
MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow | |
| 2012-08-21 | — | Oncentra External Beam 4.1.
Radiation treatment planning software designed to analyze and plan radi | |
| 2012-08-06 | — | Precise Digital Accelerator
Delivery of radiation to defined target volumes | |
| 2012-07-27 | — | Multileaf Collimator
To be used for single or multiple fractions, delivered as static and/or dynami | |
| 2012-06-21 | — | Monaco
Product Usage:
Planning of radiation therapy | |
| 2012-06-21 | — | Focal SIM
Planning of radiation therapy | |
| 2012-04-19 | — | MLCi/MCLi2.
Radiation therapy. | |
| 2012-01-26 | — | Elekta Synergy XVI 4.5 and R4.6
To be used as part of radiation therapy treatment process. | |
| 2011-10-20 | — | Elekta Synergy XVI X-ray Volume Imaging System
To be used as part of radiation therapy treatment pr | |
| 2011-10-14 | — | Elekta Synergy XVI R.4.5 and R4.6
ProducT Usage: To be used as part of radiation therapy treatment | |
| 2011-06-23 | — | Elekta Leksell Gamma Plan
Product Usage: Gamma Plan is a computer based system designed for Gamma | |
| 2011-05-26 | — | Elekta Leksell Gamma Knife C 1.2, 4 and 4C
Product Usage: Leksell Gamma Knife is a teletherapy de | |
| 2011-05-25 | — | Dynamic Multileaf Collimator (DMLC)
Shapes the radiation beam in treatment therapy. | |
| 2011-05-06 | — | Elekta Synergy
The Elekta Synergy System is intended to be used for radiation therapy treatment of | |
| 2011-03-25 | — | Stereotactic Circular Collimator
Product Usage: This device is intended to hold a patient's head i | |
| 2011-03-09 | — | Elekta Synergy XVI 4.5
Product Usage: Radiation therapy treatment of malignant neoplastic diseases | |
| 2011-01-05 | — | Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as d | |
| 2010-10-25 | — | Elekta Synergy XVI R4.5
Radiation therapy treatment of malignant neoplastic diseases, as determine | |
| 2010-10-14 | — | Elekta VBH Head FIX
The VBH HeadFIX is intended for positioning and immobilization of the head and n | |
| 2010-09-17 | — | Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockh | |
| 2010-09-01 | — | Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as d | |
| 2009-11-06 | — | Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekt | |
| 2009-10-02 | — | Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery us | |
| 2009-07-31 | — | iView GT Electronic Portal Imaging Device, used with radiation therapy treatments. | |
| 2008-12-12 | — | Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norc | |
| 2008-11-09 | — | Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta | |
| 2008-10-23 | — | Leksell GammaPlan.
Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured | |
| 2008-09-30 | — | PrecisePLAN 2.15 Treatment Planning System.
The product is used to plan multiple beam radiation th | |
| 2008-03-18 | — | Elekta Synergy
Intended to be used for radiation therapy treatment of malignant neoplastic diseases | |
| 2008-03-10 | — | Precise Treatment Table
The Precise Treatment Table is intended as a universal patient treatment sup | |
| 2008-02-05 | — | PrecisePLAN Treatment Planning System
Intended use: To plan multiple beam radiation therapy treatme | |
| 2008-01-28 | — | PrecisePLAN Treatment Planning System
To plan multiple beam radiation therapy treatments. | |
| 2008-01-07 | — | Leksell GammaPlan 8.0 image fusion
Leksell GammaPlan is designed for use with the Leksell Gamma Kni | |
| 2007-10-01 | — | Leksell Gamma Knife.
Leksell Gamma Knife is a teletherapy device indicated for use in the stereotac | |
| 2007-09-19 | — | Elekta Synergy XVI
The intended use: Radiation therapy treatment of malignant neoplastic diseases, | |
| 2007-08-23 | — | Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2
A user interface of rthe SL/SLi Series Linear Accelerators that | |
| 2007-07-02 | — | Leksell Gamma Knife Perfexion, Article #715000.
Teletherapy device intended for stereotactic irradi | |
| 2007-05-30 | — | Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.
| |
| 2007-01-11 | — | Precise Treatment Table
Intended as a universal patient treatment support and positioning table for | |
| 2006-11-23 | — | Desktop Pro R6.0 & R6.1, Linear Medical Accelerator. | |
| 2006-09-01 | — | Leksell Gamma Knife C | |
| 2006-08-01 | — | Leksell Gamma Knife C | |
| 2006-03-15 | — | PrecisePLAN 2.10 Treatment Planning System | |
| 2005-10-01 | — | Leksell GammaPlan, Model 5.34.
Intended to be used for planning the dosimetry of treatments in ster | |
| 2005-10-01 | — | Elekta SL Series/Precise Digital Accelerator.
The product is used with radiation therapy treatment | |
| 2005-05-23 | — | Leksell SurgiPlan | |