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) |
|---|---|---|---|
| Apr 20, 2010 | Varian Medical Systems Oncology Systems Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy. Terminated |
MUJ | K073020 |
| Apr 16, 2010 | Elekta, Inc. PrecisePLAN 2.10 Treatment Planning System Terminated |
MUJ | K022411 |
| Mar 25, 2010 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, Release 4.51.00. Terminated |
MUJ | K092132 |
| Mar 16, 2010 | Elekta, Inc. PrecisePLAN 2.15 Treatment Planning System.
The product is used to plan multiple beam radiation therapy treatments. Terminated |
MUJ | K022411 |
| Sep 22, 2009 | Varian Medical Systems Oncology Systems Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Terminated |
MUJ | K071873 |
| Sep 21, 2009 | TomoTherapy Incorporated TomoTherapy Hi-Art System, Version 3.X
ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717.
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and Terminated |
MUJ | K060912 |
| Sep 20, 2009 | Brainlab AG BrainLab Radiotherapy Treatment Planning Software;
Catalog number 20610 - Radiosurgery 3.0
Catalog number 20620 - Radiosurgery 3.5 and
Catalog number 20630 - Circular ARC SRS/SRT Planning.
The soft Terminated |
MUJ | K002509 K080888 +2 |
| Jan 15, 2009 | Varian Medical Systems Oncology Systems Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA.
Indicated for planning proton tr Terminated |
MUJ | K071873 |
| Sep 23, 2008 | Varian Medical Systems Oncology Systems Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48 Terminated |
MUJ | K071873 |
| Sep 17, 2008 | Brainlab AG VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapell Terminated |
MUJ | K023651 |
| Dec 12, 2007 | Accuray Inc Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089. Terminated |
MUJ | K052325 |
| Sep 25, 2007 | Philips Nuclear Medicine, Inc. The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM Terminated |
MUJ | K041577 |
| Aug 7, 2004 | Varian Medical Systems Inc medical device and software systems Terminated |
MUJ | None listed |
| Jul 20, 2004 | Radionics, Inc. Radionics Head and Neck Localilizer (HNL), Version B Terminated |
MUJ | K991237 |
| Jul 20, 2004 | ADAC Laboratories Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number 9200-0613B-ENG Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 7.0e CD, Part Number Part # 9104-2011A Rev. A Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG Terminated |
MUJ | None listed |
| Jul 20, 2004 | ADAC Laboratories Pinnacle3 Radiation Therapy Planning System, Version 7.0e Kit, Model Number 9200-9052A-ENG Terminated |
MUJ | K032724 |
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