FDA Product Code
FDA Product Code MUJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 257 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2015-08-13 | Traditional | PDF ↗ |
| K151369 | .decimal p.d | .Decimal, LLC | 2015-08-07 | Traditional | PDF ↗ |
| K151233 | Monaco | Impac Medical Systems, Inc. | 2015-07-07 | Traditional | PDF ↗ |
| K141900 | SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE | Eckert & Ziegler Bebig GmbH | 2015-05-20 | Traditional | PDF ↗ |
| K150547 | .decimal Astroid Dosimetry App | .Decimal, Inc. | 2015-05-15 | Traditional | PDF ↗ |
| K143269 | Delivery Analysis | Accuray Incorporated | 2015-04-14 | Traditional | PDF ↗ |
| K142108 | RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS | Brainlab AG | 2014-12-16 | Traditional | PDF ↗ |
| K141860 | RAYSTATION | Raysearch Laboratories AB | 2014-10-23 | Traditional | PDF ↗ |
| K141248 | SMART SEGMENTATION KNOWLEDGE BASED CONTOURING | Varian Medical Systems, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K141283 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2014-08-07 | Traditional | PDF ↗ |
| K132816 | ONCENTRA BRACHY | Nucletron B.V. | 2014-06-13 | Traditional | PDF ↗ |
| K140187 | RAY STATION | Raysearch Laboratories AB | 2014-05-15 | Traditional | PDF ↗ |
| K133247 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2014-02-07 | Traditional | PDF ↗ |
| K133655 | RADIANCE V2 | Gmv Soluciones Globales Internet S.A.U. | 2014-01-31 | Traditional | PDF ↗ |
| K133331 | 4D INTEGRATED TREATMENT CONSOLE | Varian Medical Systems, Inc. | 2014-01-27 | Traditional | PDF ↗ |
| K132971 | MONACO | Impac Medical Systems, Inc. | 2013-11-20 | Traditional | PDF ↗ |
| K131891 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2013-09-25 | Traditional | PDF ↗ |
| K131428 | RADVISION | Acoustic Medsystems, Inc. | 2013-07-16 | Traditional | PDF ↗ |
| K130617 | RAYSTATION | Raysearch Laboratories AB | 2013-05-10 | Traditional | PDF ↗ |
| K123263 | HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS | Eckert & Ziegler Bebig GmbH | 2013-04-04 | Abbreviated | PDF ↗ |
| K123357 | ONQ RTS | Oncology Systems, Inc. | 2012-12-28 | Traditional | PDF ↗ |
| K123152 | VITESSE 3.0 | Varian Medical Systems, Oncology Systems | 2012-12-07 | Traditional | PDF ↗ |
| K121448 | ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY | Elekta Inc. D/B/A Nucletron Corporation | 2012-07-02 | Traditional | PDF ↗ |
| K120551 | SIMUPLAN TREATMENT PLANNING SYSTEM | Simuplan S.L. | 2012-06-08 | Traditional | PDF ↗ |
| K120387 | RAYSTATION | Raysearch Laboratories AB | 2012-04-06 | Traditional | PDF ↗ |
| K120363 | SYNGO RT INTERFACE | Siemens Medical Solutions USA, Inc. | 2012-03-20 | Traditional | PDF ↗ |
| K112723 | EPIGRAY | Dosisoft SA | 2012-02-08 | Traditional | PDF ↗ |
| K112060 | RADIANCE | Gmv Aerospace and Defence S.A. | 2012-01-06 | Traditional | PDF ↗ |
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | Tomotherapy Incorporated | 2011-12-22 | Traditional | PDF ↗ |
| K113102 | ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING | Nucletron | 2011-12-12 | Traditional | PDF ↗ |
| K111311 | SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING | Omisa Inc. (Segasist Technologies) | 2011-10-17 | Traditional | PDF ↗ |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | Tomotherapy Incorporated | 2011-10-07 | Traditional | PDF ↗ |
| K103515 | EQUAL DOSE | Nucletron Corporation | 2011-09-15 | Traditional | PDF ↗ |
| K110730 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | 2011-06-24 | Traditional | PDF ↗ |
| K103246 | IPLAN RT | Brainlab AG | 2011-03-16 | Traditional | PDF ↗ |
| K103146 | ISOGRAY TREATMENT PLANNING SYSTEM | Dosisoft SA | 2011-03-11 | Traditional | PDF ↗ |
| K102915 | VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM | Viewray, Incorporated | 2011-01-12 | Traditional | PDF ↗ |
| K103093 | LEKSELL GAMMAPLAN | Elekta Instrument AB | 2010-12-21 | Traditional | PDF ↗ |
| K101220 | EXPLORER 4D TREATMENT PLANNING SYSTEM | American Radiosurgery, Inc. | 2010-11-05 | Traditional | PDF ↗ |
| K102216 | XIO RTP SYSTEM | Computerized Medical Systems, Inc. | 2010-10-01 | Traditional | PDF ↗ |
| K102011 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2010-09-03 | Traditional | PDF ↗ |
| K101076 | PROWESS PANTHER PROARC, MODEL VERSION 5.0 | Prowess, Inc. | 2010-07-27 | Traditional | PDF ↗ |
| K101119 | SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 | Siemens Medical Solutions USA, Inc. | 2010-06-16 | Traditional | PDF ↗ |
| K100056 | MEDCOM RT-VIEWER SYSTEM | Medcom GmbH | 2010-05-07 | Traditional | PDF ↗ |
| K100417 | XKNIFE 5 | Integra Radionics, Inc. | 2010-04-08 | Traditional | PDF ↗ |
| K100552 | RAYSTATION VERSION 1.0 | Raysearch Laboratories AB | 2010-03-12 | Traditional | PDF ↗ |
| K100092 | CORVUS RADIATION THERAPY PLANNING SYSTEM | Best Nomos | 2010-02-23 | Special | PDF ↗ |
| K093588 | EXPLORER 4D TREATMENT PLANNING SYSTEM | American Radiosurgery, Inc. | 2010-01-11 | Traditional | PDF ↗ |
| K093391 | SIMUPLAN TREATMENT PLANNING SYSTEM | Simuplan S.L. | 2009-12-23 | Special | PDF ↗ |
| K092928 | DOSE VOLUME HISTOGRAM (DVH) EVALUATOR | Diversilabs, LLC | 2009-12-16 | Traditional | PDF ↗ |
| K092132 | XIO RTP SYSTEM | Computerized Medical Systems, Inc. | 2009-09-24 | Traditional | PDF ↗ |
| K090972 | LEKSELL GAMMAPLAN | Elekta Instrument AB | 2009-07-20 | Special | PDF ↗ |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | Computerized Medical Systems, Inc. | 2009-07-16 | Traditional | PDF ↗ |
| K090893 | TIGRT TPS | Linatech, LLC | 2009-07-15 | Traditional | PDF ↗ |
| K091492 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2009-06-18 | Special | PDF ↗ |
| K091145 | FLEXIPLAN 3D AND 3D+ | Isodose Control B.V. | 2009-05-27 | Special | PDF ↗ |
| K090531 | RADCALC SOFTWARE, VERSION 6.0 | Lifeline Software, Inc. | 2009-05-27 | Traditional | PDF ↗ |
| K083502 | PANTHER REALART, MODEL 4.7 | Prowess, Inc. | 2009-05-05 | Traditional | PDF ↗ |
| K090182 | MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) | Nuclemed S.A. | 2009-05-04 | Traditional | PDF ↗ |
| K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray, Inc. | 2009-05-01 | Special | PDF ↗ |
| K083672 | P.D SOFTWARE | .Decimal, Inc. | 2009-04-13 | Traditional | PDF ↗ |
| K090808 | PINNACLE3 SMARTARC | Philips Medical Systems, Inc. | 2009-04-03 | Traditional | PDF ↗ |
| K083414 | RADIONICS XKNIFE HDRT SYSTEM | Integra Radionics, Inc. | 2009-03-02 | Traditional | PDF ↗ |
| K083264 | RAYAUTOPLAN 1.0 | Raysearch Laboratories AB | 2009-01-22 | Traditional | PDF ↗ |
| K082606 | COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) | D3 Radiation Planning | 2008-11-10 | Traditional | PDF ↗ |
| K082642 | ONCENTRA RT VIEWER 1.0 | Nucletron Corporation | 2008-11-07 | Traditional | PDF ↗ |
| K082221 | RAYDOSE | Raysearch Laboratories AB | 2008-10-22 | Traditional | PDF ↗ |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | Tomotherapy Incorporated | 2008-08-25 | Traditional | PDF ↗ |
| K081112 | FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM | Isodose Control B.V. | 2008-07-29 | Abbreviated | PDF ↗ |
| K080888 | MODEIFICATION TO IPLAN RT DOSE | Brainlab AG | 2008-06-11 | Special | PDF ↗ |
| K080601 | ERGO++ VERSION 1.7 | 3D Line Medical Systems S.R.L. | 2008-06-06 | Traditional | PDF ↗ |
| K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) | Nucletron Corporation | 2008-05-20 | Traditional | PDF ↗ |
| K080929 | ONCENTRA GYN | Nucletron Corporation | 2008-04-16 | Traditional | PDF ↗ |
| K073020 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2007-12-19 | Special | PDF ↗ |
| K071760 | MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K071938 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | 2007-10-01 | Traditional | PDF ↗ |
| K071873 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 2007-08-09 | Special | PDF ↗ |
| K063230 | INTEGRA RADIONICS IMAGEFUSION 3 | Integra Radionics, Inc. | 2006-12-21 | Special | PDF ↗ |
| K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 | Direx Systems Corp. | 2006-12-14 | Special | PDF ↗ |
| K062967 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray, Inc. | 2006-10-30 | Special | PDF ↗ |
| K062032 | ACCUSOFT, ACCUSOFT XL | Direx Systems Corp. | 2006-10-05 | Traditional | PDF ↗ |
| K062514 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | 2006-09-28 | Special | PDF ↗ |
| K061893 | INTEGRA RADIONICS XKNIFE RT 4 | Integra Radionics, Inc. | 2006-07-25 | Special | PDF ↗ |
| K053584 | IPLAN RT DOSE | Brainlab AG | 2006-07-12 | Special | PDF ↗ |
| K061440 | P.D | .Decimal, Inc. | 2006-06-27 | Traditional | PDF ↗ |
| K061097 | COHERENCE DOSIMETRIST, MODEL 2.2 | Siemens Medical Solutions USA, Inc. | 2006-06-07 | Traditional | PDF ↗ |
| K050296 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems | 2005-11-03 | Traditional | PDF ↗ |
| K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray Incorporated | 2005-09-14 | Special | PDF ↗ |
| K051941 | CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM | Accuray, Inc. | 2005-08-09 | Special | PDF ↗ |
| K051497 | VITESSE 2.0 | Varian Medical Systems, Inc. | 2005-07-18 | Traditional | PDF ↗ |
| K041971 | WIMRT MODULE FOR ARTP PLANNING SYSTEM | Prodigm Group, Inc. | 2005-05-20 | Traditional | PDF ↗ |
| K042861 | ODYSSEY | Permedics, Inc. | 2005-01-12 | Traditional | PDF ↗ |
| K042739 | HI-ART SYSTEM | Tomotherapy Incorporated | 2004-11-03 | Special | PDF ↗ |
| K042269 | LEKSELL GAMMAPLAN 4C WITH MULTIVIEW | Elekta Instrument AB | 2004-09-08 | Special | PDF ↗ |
| K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE | Radionics, A Division of Tyco Healthcare Group LP | 2004-08-27 | Traditional | PDF ↗ |
| K041403 | ECLIPSE WITH AAA | Varian Medical Systems | 2004-07-26 | Special | PDF ↗ |
| K031088 | TRIMED PLAN, VERSION 2.2 | Trimed Systems, Inc. | 2004-07-23 | Traditional | PDF ↗ |
| K041719 | ONCENTRA-VISIR | Nucletron Corp. | 2004-07-22 | Special | PDF ↗ |
| K040474 | ACCUSOFT | Direx Systems Corp. | 2004-06-23 | Traditional | PDF ↗ |
| K040688 | STANDARD IMAGING E.IMRT CALCULATOR | Standard Imaging, Inc. | 2004-05-11 | Traditional | PDF ↗ |
Product code MUJ · Class II · Radiology. Data: openFDA.