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Panels › Radiology › Product code MUJ · Class 2

System, Planning, Radiation Therapy Treatment

Regulation 892.5050

13510(k)s in 12 months (258 all time)
13recalls in 12 months (270 all time)
257recalls that name a 510(k)
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Top companies in MUJ

DateFirm and productCodeLinked 510(k)
Aug 11, 2011Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Product Usage: Eclipse Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or beni
Terminated
MUJK073020
Aug 3, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external
Terminated
MUJK102216
Jul 11, 2011Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy treatment for patients with malignant and benign diseases.
Terminated
MUJK102011
Jul 11, 2011Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through 10.0.34) Varian Medical Systems, Inc. Used to plan radiotherapy treatments for patients with Malignant or benign dise
Terminated
MUJK073020
Jul 7, 2011Accuray Incorporated
TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise deliv
Terminated
MUJK082005
Jun 29, 2011Varian Medical Systems, Inc. Oncology Systems
Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..
Terminated
MUJK073020
Jun 23, 2011Computerized Medical Systems Inc
Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioac
Terminated
MUJK982696
Jun 23, 2011Computerized Medical Systems Inc
ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy
Terminated
MUJK080601
Jun 20, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
Terminated
MUJK092132
Jun 20, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to acc
Terminated
MUJK013112
Jun 20, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed
Terminated
MUJK092132
Jun 20, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
Terminated
MUJK092132
Jun 20, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to
Terminated
MUJK013112
Jun 20, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software a
Terminated
MUJK013112
Jun 20, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal softwar
Terminated
MUJK013112
Jun 20, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) h
Terminated
MUJK071938
K091179
Jun 17, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescrib
Terminated
MUJK102216
Jun 16, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pres
Terminated
MUJK092132
Jun 16, 2011Computerized Medical Systems Inc
XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pre
Terminated
MUJK092163
Jun 16, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed
Terminated
MUJK092132
Jun 15, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users
Terminated
MUJK013112
Jun 15, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pr
Terminated
MUJK092132
Jun 15, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pre
Terminated
MUJK092132
Jun 15, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribe
Terminated
MUJK092132
Jun 15, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (
Terminated
MUJK071938
K091179
Jun 14, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has
Terminated
MUJK071938
K091179
Jun 14, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMR
Terminated
MUJK071938
K091179
Jun 14, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users
Terminated
MUJK013112
Jun 14, 2011Computerized Medical Systems Inc
Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability t
Terminated
MUJK013112
Jun 14, 2011Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity mo
Terminated
MUJK071938
K091179
Jun 3, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribe
Terminated
MUJK092132
Jun 2, 2011Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescrib
Terminated
MUJK092132
May 25, 2011Elekta, Inc.
Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Terminated
MUJK001163
May 19, 2011Varian Medical Systems, Inc. Oncology Systems
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Tre
Terminated
MUJK073020
Mar 28, 2011Siemens Medical Solutions USA, Inc
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
Terminated
MUJK022307
K061097
Mar 14, 2011TomoTherapy Incorporated
TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radio
Terminated
MUJK082005
Mar 4, 2011Elekta, Inc.
PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.
Terminated
MUJK022411
Mar 2, 2011Elekta, Inc.
PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
Terminated
MUJK022411
Feb 2, 2011Accuray Inc
Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. F
Terminated
MUJK091146
Feb 1, 2011Accuray Inc
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation thera
Terminated
MUJK091146
Jan 18, 2011Varian Medical Systems, Palo Alto, CA
Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System
Terminated
MUJK071873
Jan 10, 2011Accuray Inc
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for tre
Terminated
MUJK091146
Dec 27, 2010TomoTherapy Incorporated
ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or
Terminated
MUJK082005
Nov 24, 2010Varian Medical Systems Oncology Systems
Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Num
Terminated
MUJK071873
K932501
Oct 28, 2010Impac Medical Systems Inc
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification syst
Terminated
MUJK981313
Aug 12, 2010TomoTherapy Incorporated
Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy,
Terminated
MUJK082005
Aug 2, 2010TomoTherapy Incorporated
TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for planning and precise delivery of radi
Terminated
MUJK082005
Jul 22, 2010TomoTherapy Incorporated
TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to be used as an integrated system for th
Terminated
MUJK082005
May 26, 2010Computerized Medical Systems Inc
Elekta XiO Radiation Treatment Planning System
Terminated
MUJK092132
May 18, 2010PerMedics, Inc.
Odyssey Intended use: Radiation treatment planning system
Terminated
MUJK042861

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