30 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·January 18, 2017
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·February 6, 2013
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·May 22, 2013
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·July 20, 2016
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·July 20, 2016
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 26, 2012
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems Inc·July 1, 2015
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·February 6, 2013
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems Inc·July 8, 2015
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·January 1, 2014
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·November 4, 2015
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·October 30, 2013
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·February 24, 2016
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·October 19, 2016
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·January 30, 2019