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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2009 | K092928 | DOSE VOLUME HISTOGRAM (DVH) EVALUATOR Diversilabs, LLC | MUJ |
| Sep 24, 2009 | K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Jul 20, 2009 | K090972 | LEKSELL GAMMAPLAN Elekta Instrument AB, SE | MUJ |
| Jul 16, 2009 | K091179 | MONACO RTP SYSTEM, VMAT OPTION Computerized Medical Systems, Inc. | MUJ |
| Jul 15, 2009 | K090893 | TIGRT TPS Linatech, LLC | MUJ |
| Jun 18, 2009 | K091492 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. | MUJ |
| May 27, 2009 | K091145 | FLEXIPLAN 3D AND 3D+ Isodose Control B.V., NL | MUJ |
| May 27, 2009 | K090531 | RADCALC SOFTWARE, VERSION 6.0 Lifeline Software, Inc. | MUJ |
| May 5, 2009 | K083502 | PANTHER REALART, MODEL 4.7 Prowess, Inc. | MUJ |
| May 4, 2009 | K090182 | MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) Nuclemed S.A. | MUJ |
| May 1, 2009 | K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. | MUJ |
| Apr 13, 2009 | K083672 | P.D SOFTWARE .Decimal, Inc. | MUJ |
| Apr 3, 2009 | K090808 | PINNACLE3 SMARTARC Philips Medical Systems, Inc. | MUJ |
| Mar 2, 2009 | K083414 | RADIONICS XKNIFE HDRT SYSTEM Integra Radionics, Inc. | MUJ |
| Jan 22, 2009 | K083264 | RAYAUTOPLAN 1.0 Raysearch Laboratories AB, SE | MUJ |
| Nov 10, 2008 | K082606 | COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) D3 Radiation Planning | MUJ |
| Nov 7, 2008 | K082642 | ONCENTRA RT VIEWER 1.0 Nucletron Corporation | MUJ |
| Oct 22, 2008 | K082221 | RAYDOSE Raysearch Laboratories AB, SE | MUJ |
| Aug 25, 2008 | K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM Tomotherapy Incorporated | MUJ |
| Jul 29, 2008 | K081112 | FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM Isodose Control B.V., NL | MUJ |
| Jun 11, 2008 | K080888 | MODEIFICATION TO IPLAN RT DOSE Brainlab AG, DE | MUJ |
| Jun 6, 2008 | K080601 | ERGO++ VERSION 1.7 3D Line Medical Systems S.R.L. | MUJ |
| May 20, 2008 | K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) Nucletron Corporation | MUJ |
| Apr 16, 2008 | K080929 | ONCENTRA GYN Nucletron Corporation | MUJ |
| Dec 19, 2007 | K073020 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. | MUJ |
| Nov 9, 2007 | K071760 | MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. | MUJ |
| Oct 1, 2007 | K071938 | MONACO RTP SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Aug 9, 2007 | K071873 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. | MUJ |
| Dec 21, 2006 | K063230 | INTEGRA RADIONICS IMAGEFUSION 3 Integra Radionics, Inc. | MUJ |
| Dec 14, 2006 | K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 Direx Systems Corp. | MUJ |
| Oct 30, 2006 | K062967 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. | MUJ |
| Oct 5, 2006 | K062032 | ACCUSOFT, ACCUSOFT XL Direx Systems Corp. | MUJ |
| Sep 28, 2006 | K062514 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated | MUJ |
| Jul 25, 2006 | K061893 | INTEGRA RADIONICS XKNIFE RT 4 Integra Radionics, Inc. | MUJ |
| Jul 12, 2006 | K053584 | IPLAN RT DOSE Brainlab AG, DE | MUJ |
| Jun 27, 2006 | K061440 | P.D .Decimal, Inc. | MUJ |
| Jun 7, 2006 | K061097 | COHERENCE DOSIMETRIST, MODEL 2.2 Siemens Medical Solutions USA, Inc. | MUJ |
| Nov 3, 2005 | K050296 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems | MUJ |
| Sep 14, 2005 | K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY Accuray Incorporated | MUJ |
| Aug 9, 2005 | K051941 | CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM Accuray, Inc. | MUJ |
| Jul 18, 2005 | K051497 | VITESSE 2.0 Varian Medical Systems, Inc. | MUJ |
| May 20, 2005 | K041971 | WIMRT MODULE FOR ARTP PLANNING SYSTEM Prodigm Group, Inc. | MUJ |
| Jan 12, 2005 | K042861 | ODYSSEY Permedics, Inc. | MUJ |
| Nov 3, 2004 | K042739 | HI-ART SYSTEM Tomotherapy Incorporated | MUJ |
| Sep 8, 2004 | K042269 | LEKSELL GAMMAPLAN 4C WITH MULTIVIEW Elekta Instrument AB, SE | MUJ |
| Aug 27, 2004 | K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE Radionics, A Division of Tyco Healthcare Group LP | MUJ |
| Jul 26, 2004 | K041403 | ECLIPSE WITH AAA Varian Medical Systems | MUJ |
| Jul 23, 2004 | K031088 | TRIMED PLAN, VERSION 2.2 Trimed Systems, Inc. | MUJ |
| Jul 22, 2004 | K041719 | ONCENTRA-VISIR Nucletron Corp. | MUJ |
| Jun 23, 2004 | K040474 | ACCUSOFT Direx Systems Corp. | MUJ |
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