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)
Top companies in MUJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2011 | Varian 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 |
MUJ | K073020 |
| Aug 3, 2011 | Computerized 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 |
MUJ | K102216 |
| Jul 11, 2011 | Varian 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 |
MUJ | K102011 |
| Jul 11, 2011 | Varian 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 |
MUJ | K073020 |
| Jul 7, 2011 | Accuray 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 |
MUJ | K082005 |
| Jun 29, 2011 | Varian Medical Systems, Inc. Oncology Systems Eclipse Radiation Treatment Planning System, model H48;
Varian Medical Systems Inc.. Terminated |
MUJ | K073020 |
| Jun 23, 2011 | Computerized 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 |
MUJ | K982696 |
| Jun 23, 2011 | Computerized 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 |
MUJ | K080601 |
| Jun 20, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Terminated |
MUJ | K092132 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 20, 2011 | Computerized 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 |
MUJ | K071938 K091179 |
| Jun 17, 2011 | Computerized 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 |
MUJ | K102216 |
| Jun 16, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 16, 2011 | Computerized 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 |
MUJ | K092163 |
| Jun 16, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 15, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 15, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 15, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 15, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 15, 2011 | Computerized 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 |
MUJ | K071938 K091179 |
| Jun 14, 2011 | Computerized 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 |
MUJ | K071938 K091179 |
| Jun 14, 2011 | Computerized 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 |
MUJ | K071938 K091179 |
| Jun 14, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 14, 2011 | Computerized 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 |
MUJ | K013112 |
| Jun 14, 2011 | Computerized 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 |
MUJ | K071938 K091179 |
| Jun 3, 2011 | Computerized 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 |
MUJ | K092132 |
| Jun 2, 2011 | Computerized 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 |
MUJ | K092132 |
| May 25, 2011 | Elekta, Inc. Dynamic Multileaf Collimator (DMLC)
Shapes the radiation beam in treatment therapy. Terminated |
MUJ | K001163 |
| May 19, 2011 | Varian 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 |
MUJ | K073020 |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc Coherence Dosimetrist, version 2.2.
Intended use: Medical charged-particle radiation therapy system Terminated |
MUJ | K022307 K061097 |
| Mar 14, 2011 | TomoTherapy 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 |
MUJ | K082005 |
| Mar 4, 2011 | Elekta, Inc. PrecisePLAN Treatment Planning System
Intended use: To plan multiple beam radiation therapy treatments. Terminated |
MUJ | K022411 |
| Mar 2, 2011 | Elekta, Inc. PrecisePLAN Treatment Planning System
To plan multiple beam radiation therapy treatments. Terminated |
MUJ | K022411 |
| Feb 2, 2011 | Accuray 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 |
MUJ | K091146 |
| Feb 1, 2011 | Accuray 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 |
MUJ | K091146 |
| Jan 18, 2011 | Varian 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 |
MUJ | K071873 |
| Jan 10, 2011 | Accuray 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 |
MUJ | K091146 |
| Dec 27, 2010 | TomoTherapy 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 |
MUJ | K082005 |
| Nov 24, 2010 | Varian 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 |
MUJ | K071873 K932501 |
| Oct 28, 2010 | Impac 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 |
MUJ | K981313 |
| Aug 12, 2010 | TomoTherapy 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 |
MUJ | K082005 |
| Aug 2, 2010 | TomoTherapy 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 |
MUJ | K082005 |
| Jul 22, 2010 | TomoTherapy 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 |
MUJ | K082005 |
| May 26, 2010 | Computerized Medical Systems Inc Elekta XiO Radiation Treatment Planning System Terminated |
MUJ | K092132 |
| May 18, 2010 | PerMedics, Inc. Odyssey
Intended use: Radiation treatment planning system Terminated |
MUJ | K042861 |
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