MUJ · System, Planning, Radiation Therapy Treatment
Radiology · 21 CFR 892.5050 · Class 2
Overview
| Product Code | MUJ |
|---|---|
| Device Name | System, Planning, Radiation Therapy Treatment |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Cleared Devices (252)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | Mar 18, 2026 | SESE |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | Feb 19, 2026 | SESE |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | Feb 19, 2026 | SESE |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | Dec 23, 2025 | SESE |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | Dec 22, 2025 | SESE |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | Dec 19, 2025 | SESE |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | Nov 20, 2025 | SESE |
| K250064 | Dose+ (1.0) | Mvision AI OY | Sep 4, 2025 | SESE |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | Jun 17, 2025 | SESE |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | Apr 17, 2025 | SESE |
| K242748 | Oncospace | Oncospace, Inc. | Apr 11, 2025 | SESE |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | Apr 4, 2025 | SESE |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | Feb 25, 2025 | SESE |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | Dec 13, 2024 | SESE |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | Dec 11, 2024 | SESE |
| K240671 | XBeam (v2) | Xstrahl, Ltd. | Dec 4, 2024 | SESE |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | Oct 23, 2024 | SESE |
| K241876 | Vitesse (5.0) | Varian Medical Systems | Oct 23, 2024 | SESE |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | Aug 30, 2024 | SESE |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | May 17, 2024 | SESE |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Apr 26, 2024 | SESE |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | Apr 22, 2024 | SESE |
| K232479 | ART-Plan | Therapanacea | Dec 22, 2023 | SESE |
| K231825 | Panther TPS | Prowess, Inc. | Dec 15, 2023 | SESE |
| K232400 | VariSeed (v10) | Varian Medical Systems | Sep 8, 2023 | SESE |
| K223724 | MOZI TPS | Manteia Technologies Co., Ltd. | Jul 10, 2023 | SESE |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | May 26, 2023 | SESE |
| K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | May 17, 2023 | SESE |
| K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | Mar 29, 2023 | SESE |
| K223279 | RT Elements (4.0) | Brainlab AG | Mar 14, 2023 | SESE |
| K223233 | Monaco RTP System | Elekta Solutions AB | Feb 23, 2023 | SESE |
| K222803 | Oncospace | Oncospace, Inc. | Feb 2, 2023 | SESE |
| K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Sep 7, 2022 | SESE |
| K211841 | MRI Planner | Spectronic Medical AB | Aug 25, 2022 | SESE |
| K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | Aug 22, 2022 | SESE |
| K213787 | Monaco RTP System | Elekta Solutions AB | May 17, 2022 | SESE |
| K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | Apr 15, 2022 | SESE |
| K212274 | INT Contour | Carina Medical, LLC | Apr 8, 2022 | SESE |
| K214081 | MRCAT Head & Neck | Philips OY | Apr 5, 2022 | SESE |
| K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory | Adaptiiv | Jan 19, 2022 | SESE |
| K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | Sep 8, 2021 | SESE |
| K211881 | AI Segmentation | Varian Medical Systems, Inc. | Sep 2, 2021 | SESE |
| K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Jul 30, 2021 | SESE |
| K211511 | decimal Bolus | .Decimal, LLC | Jul 1, 2021 | SESE |
| K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | Jun 29, 2021 | SESE |
| K211034 | Corvus Radiation Therapy Planning System | Best Nomos | May 6, 2021 | SESE |
| K203469 | AI Segmentation | Varian Medical Systems, Inc. | Apr 19, 2021 | SESE |
| K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review | Brainlab AG | Apr 9, 2021 | SESE |
| K202284 | Oncospace | Oncospace, Inc. | Mar 12, 2021 | SESE |
| K202789 | Monaco Rtp System | Elekta Solutions AB | Feb 23, 2021 | SESE |
| K203766 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | Feb 12, 2021 | SESE |
| K200569 | RayStation | RaySearch Laboratories AB (PUBL) | Sep 24, 2020 | SESE |
| K201350 | CORVUS | Best Nomos | Sep 20, 2020 | SESE |
| K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Aug 13, 2020 | SESE |
| K201607 | Eclipse Treatment Planning System v16.1 | Varian Medical Systems, Inc. | Jul 10, 2020 | SESE |
| K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | Jun 10, 2020 | SESE |
| K193459 | Panther Stereotactic | Prowess, Inc. | Apr 27, 2020 | SESE |
| K193640 | ClearCalc | Radformation, Inc. | Apr 9, 2020 | SESE |
| K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | Apr 3, 2020 | SESE |
| K193109 | MRCAT brain | Philips Medical Systems MR Finland | Jan 24, 2020 | SESE |
| K193381 | RadCalc Software | Lifeline Software, Inc. | Dec 31, 2019 | SESE |
| K192554 | decimal3D | .Decimal, LLC | Dec 13, 2019 | SESE |
| K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | Sep 18, 2019 | SESE |
| K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | Jul 8, 2019 | SESE |
| K190387 | RayStation | RaySearch Laboratories AB (PUBL) | Jun 19, 2019 | SESE |
| K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | Apr 30, 2019 | SESE |
| K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG | Apr 12, 2019 | SESE |
| K190178 | Monaco RTP System | Elekta, Inc. | Mar 29, 2019 | SESE |
| K182665 | Sensus TPS Workstation | Sensus Healthcare, Inc. | Feb 21, 2019 | SESE |
| K183037 | Monaco RTP System | Elekta, Inc. | Dec 4, 2018 | SESE |
| K180289 | 3D Bolus Software | 3D Bolus, Inc. | Jul 10, 2018 | SESE |
| K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | May 18, 2018 | SESE |
| K173940 | Astroid Planning App | .Decimal, LLC | May 15, 2018 | SESE |
| K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | Apr 25, 2018 | SESE |
| K180308 | Prelude | Medcom GmbH | Mar 27, 2018 | SESE |
| K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Jan 12, 2018 | SESE |
| K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG | Aug 24, 2017 | SESE |
| K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | Aug 15, 2017 | SESE |
| K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | Jul 25, 2017 | SESE |
| K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | Jul 5, 2017 | SESE |
| K171536 | RayStation | RaySearch Laboratories AB (PUBL) | Jun 27, 2017 | SESE |
| K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | Mar 2, 2017 | SESE |
| K170086 | Pinnacle Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | Feb 9, 2017 | SESE |
| K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Oct 25, 2016 | SESE |
| K161136 | Precision Treatment Planning System | Accuray Incorporated | Jun 24, 2016 | SESE |
| K160093 | RayStation | RaySearch Laboratories AB (PUBL) | Apr 8, 2016 | SESE |
| K151435 | MRCAT | Philips Medical Systems MR Finland | Feb 25, 2016 | SESE |
| K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | Feb 16, 2016 | SESE |
| K143514 | Panther StereoSeed | Prowess, Inc. | Dec 11, 2015 | SESE |
| K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | Nov 25, 2015 | SESE |
| K152488 | Onrad Treatment System | Accuray Incorporated | Sep 28, 2015 | SESE |
| K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | Sep 18, 2015 | SESE |
| K151887 | syngo VSim | Siemens Medical Solutions USA, Inc. | Sep 16, 2015 | SESE |
| K151560 | QuickPlan | Siris Medical | Sep 11, 2015 | SESE |
| K151666 | Leksell GammaPlan | Elekta Instrument AB | Sep 3, 2015 | SESE |
| K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Aug 13, 2015 | SESE |
| K151369 | .decimal p.d | .Decimal, LLC | Aug 7, 2015 | SESE |
| K151233 | Monaco | Impac Medical Systems, Inc. | Jul 7, 2015 | SESE |
| K141900 | SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE | Eckert & Ziegler Bebig GmbH | May 20, 2015 | SESE |
| K150547 | .decimal Astroid Dosimetry App | .Decimal, Inc. | May 15, 2015 | SESE |
| K143269 | Delivery Analysis | Accuray Incorporated | Apr 14, 2015 | SESE |
| K142108 | RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS | Brainlab AG | Dec 16, 2014 | SESE |
| K141860 | RAYSTATION | Raysearch Laboratories AB | Oct 23, 2014 | SESE |
| K141248 | SMART SEGMENTATION KNOWLEDGE BASED CONTOURING | Varian Medical Systems, Inc. | Sep 5, 2014 | SESE |
| K141283 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Aug 7, 2014 | SESE |
| K132816 | ONCENTRA BRACHY | Nucletron B.V. | Jun 13, 2014 | SESE |
| K140187 | RAY STATION | Raysearch Laboratories AB | May 15, 2014 | SESE |
| K133247 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Feb 7, 2014 | SESE |
| K133655 | RADIANCE V2 | Gmv Soluciones Globales Internet S.A.U. | Jan 31, 2014 | SESE |
| K133331 | 4D INTEGRATED TREATMENT CONSOLE | Varian Medical Systems, Inc. | Jan 27, 2014 | SESE |
| K132971 | MONACO | Impac Medical Systems, Inc. | Nov 20, 2013 | SESE |
| K131891 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Sep 25, 2013 | SESE |
| K131428 | RADVISION | Acoustic Medsystems, Inc. | Jul 16, 2013 | SESE |
| K130617 | RAYSTATION | Raysearch Laboratories AB | May 10, 2013 | SESE |
| K123263 | HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS | Eckert & Ziegler Bebig GmbH | Apr 4, 2013 | SESE |
| K123357 | ONQ RTS | Oncology Systems, Inc. | Dec 28, 2012 | SESE |
| K123152 | VITESSE 3.0 | Varian Medical Systems, Oncology Systems | Dec 7, 2012 | SESE |
| K121448 | ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY | Elekta Inc. D/B/A Nucletron Corporation | Jul 2, 2012 | SESE |
| K120551 | SIMUPLAN TREATMENT PLANNING SYSTEM | Simuplan S.L. | Jun 8, 2012 | SESE |
| K120387 | RAYSTATION | Raysearch Laboratories AB | Apr 6, 2012 | SESE |
| K120363 | SYNGO RT INTERFACE | Siemens Medical Solutions USA, Inc. | Mar 20, 2012 | SESE |
| K112723 | EPIGRAY | Dosisoft SA | Feb 8, 2012 | SESE |
| K112060 | RADIANCE | Gmv Aerospace and Defence S.A. | Jan 6, 2012 | SESE |
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | Tomotherapy Incorporated | Dec 22, 2011 | SESE |
| K113102 | ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING | Nucletron | Dec 12, 2011 | SESE |
| K111311 | SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING | Omisa Inc. (Segasist Technologies) | Oct 17, 2011 | SESE |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | Tomotherapy Incorporated | Oct 7, 2011 | SESE |
| K103515 | EQUAL DOSE | Nucletron Corporation | Sep 15, 2011 | SESE |
| K110730 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | Jun 24, 2011 | SESE |
| K103246 | IPLAN RT | Brainlab AG | Mar 16, 2011 | SESE |
| K103146 | ISOGRAY TREATMENT PLANNING SYSTEM | Dosisoft SA | Mar 11, 2011 | SESE |
| K102915 | VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM | Viewray, Incorporated | Jan 12, 2011 | SESE |
| K103093 | LEKSELL GAMMAPLAN | Elekta Instrument AB | Dec 21, 2010 | SESE |
| K101220 | EXPLORER 4D TREATMENT PLANNING SYSTEM | American Radiosurgery, Inc. | Nov 5, 2010 | SESE |
| K102216 | XIO RTP SYSTEM | Computerized Medical Systems, Inc. | Oct 1, 2010 | SESE |
| K102011 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Sep 3, 2010 | SESE |
| K101076 | PROWESS PANTHER PROARC, MODEL VERSION 5.0 | Prowess, Inc. | Jul 27, 2010 | SESE |
| K101119 | SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 | Siemens Medical Solutions USA, Inc. | Jun 16, 2010 | SESE |
| K100056 | MEDCOM RT-VIEWER SYSTEM | Medcom GmbH | May 7, 2010 | SESE |
| K100417 | XKNIFE 5 | Integra Radionics, Inc. | Apr 8, 2010 | SESE |
| K100552 | RAYSTATION VERSION 1.0 | Raysearch Laboratories AB | Mar 12, 2010 | SESE |
| K100092 | CORVUS RADIATION THERAPY PLANNING SYSTEM | Best Nomos | Feb 23, 2010 | SESE |
| K093588 | EXPLORER 4D TREATMENT PLANNING SYSTEM | American Radiosurgery, Inc. | Jan 11, 2010 | SESE |
| K093391 | SIMUPLAN TREATMENT PLANNING SYSTEM | Simuplan S.L. | Dec 23, 2009 | SESE |
| K092928 | DOSE VOLUME HISTOGRAM (DVH) EVALUATOR | Diversilabs, LLC | Dec 16, 2009 | SESE |
| K092132 | XIO RTP SYSTEM | Computerized Medical Systems, Inc. | Sep 24, 2009 | SESE |
| K090972 | LEKSELL GAMMAPLAN | Elekta Instrument AB | Jul 20, 2009 | SESE |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | Computerized Medical Systems, Inc. | Jul 16, 2009 | SESE |
| K090893 | TIGRT TPS | Linatech, LLC | Jul 15, 2009 | SESE |
| K091492 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Jun 18, 2009 | SESE |
| K091145 | FLEXIPLAN 3D AND 3D+ | Isodose Control B.V. | May 27, 2009 | SESE |
| K090531 | RADCALC SOFTWARE, VERSION 6.0 | Lifeline Software, Inc. | May 27, 2009 | SESE |
| K083502 | PANTHER REALART, MODEL 4.7 | Prowess, Inc. | May 5, 2009 | SESE |
| K090182 | MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) | Nuclemed S.A. | May 4, 2009 | SESE |
| K091146 | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray, Inc. | May 1, 2009 | SESE |
| K083672 | P.D SOFTWARE | .Decimal, Inc. | Apr 13, 2009 | SESE |
| K090808 | PINNACLE3 SMARTARC | Philips Medical Systems, Inc. | Apr 3, 2009 | SESE |
| K083414 | RADIONICS XKNIFE HDRT SYSTEM | Integra Radionics, Inc. | Mar 2, 2009 | SESE |
| K083264 | RAYAUTOPLAN 1.0 | Raysearch Laboratories AB | Jan 22, 2009 | SESE |
| K082606 | COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) | D3 Radiation Planning | Nov 10, 2008 | SESE |
| K082642 | ONCENTRA RT VIEWER 1.0 | Nucletron Corporation | Nov 7, 2008 | SESE |
| K082221 | RAYDOSE | Raysearch Laboratories AB | Oct 22, 2008 | SESE |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | Tomotherapy Incorporated | Aug 25, 2008 | SESE |
| K081112 | FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM | Isodose Control B.V. | Jul 29, 2008 | SESE |
| K080888 | MODEIFICATION TO IPLAN RT DOSE | Brainlab AG | Jun 11, 2008 | SESE |
| K080601 | ERGO++ VERSION 1.7 | 3D Line Medical Systems S.R.L. | Jun 6, 2008 | SESE |
| K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) | Nucletron Corporation | May 20, 2008 | SESE |
| K080929 | ONCENTRA GYN | Nucletron Corporation | Apr 16, 2008 | SESE |
| K073020 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Dec 19, 2007 | SESE |
| K071760 | MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Nov 9, 2007 | SESE |
| K071938 | MONACO RTP SYSTEM | Computerized Medical Systems, Inc. | Oct 1, 2007 | SESE |
| K071873 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | Aug 9, 2007 | SESE |
| K063230 | INTEGRA RADIONICS IMAGEFUSION 3 | Integra Radionics, Inc. | Dec 21, 2006 | SESE |
| K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 | Direx Systems Corp. | Dec 14, 2006 | SESE |
| K062967 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray, Inc. | Oct 30, 2006 | SESE |
| K062032 | ACCUSOFT, ACCUSOFT XL | Direx Systems Corp. | Oct 5, 2006 | SESE |
| K062514 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | Sep 28, 2006 | SESE |
| K061893 | INTEGRA RADIONICS XKNIFE RT 4 | Integra Radionics, Inc. | Jul 25, 2006 | SESE |
| K053584 | IPLAN RT DOSE | Brainlab AG | Jul 12, 2006 | SESE |
| K061440 | P.D | .Decimal, Inc. | Jun 27, 2006 | SESE |
| K061097 | COHERENCE DOSIMETRIST, MODEL 2.2 | Siemens Medical Solutions USA, Inc. | Jun 7, 2006 | SESE |
| K050296 | ECLIPSE TREATMENT PLANNING SYSTEM | Varian Medical Systems | Nov 3, 2005 | SESE |
| K052325 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray Incorporated | Sep 14, 2005 | SESE |
| K051941 | CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM | Accuray, Inc. | Aug 9, 2005 | SESE |
| K051497 | VITESSE 2.0 | Varian Medical Systems, Inc. | Jul 18, 2005 | SESE |
| K041971 | WIMRT MODULE FOR ARTP PLANNING SYSTEM | Prodigm Group, Inc. | May 20, 2005 | SESE |
| K042861 | ODYSSEY | Permedics, Inc. | Jan 12, 2005 | SESE |
| K042739 | HI-ART SYSTEM | Tomotherapy Incorporated | Nov 3, 2004 | SESE |
| K042269 | LEKSELL GAMMAPLAN 4C WITH MULTIVIEW | Elekta Instrument AB | Sep 8, 2004 | SESE |
| K041997 | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE | Radionics, A Division of Tyco Healthcare Group LP | Aug 27, 2004 | SESE |
| K041403 | ECLIPSE WITH AAA | Varian Medical Systems | Jul 26, 2004 | SESE |
| K031088 | TRIMED PLAN, VERSION 2.2 | Trimed Systems, Inc. | Jul 23, 2004 | SESE |
| K041719 | ONCENTRA-VISIR | Nucletron Corp. | Jul 22, 2004 | SESE |
| K040474 | ACCUSOFT | Direx Systems Corp. | Jun 23, 2004 | SESE |
| K040688 | STANDARD IMAGING E.IMRT CALCULATOR | Standard Imaging, Inc. | May 11, 2004 | SESE |
| K031281 | ERGO SRS | 3D Line USA, Inc. | Dec 23, 2003 | SESE |
| K032456 | PROWESS | Prowess, Inc. | Oct 16, 2003 | SESE |
| K032724 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | Oct 9, 2003 | SESE |
| K030821 | SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5 | Simuplan S.L. | Sep 17, 2003 | SESE |
| K032345 | CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray, Inc. | Sep 3, 2003 | SESE |
Top Applicants
- Varian Medical Systems, Inc. — 26 clearances
- RaySearch Laboratories AB (PUBL) — 15 clearances
- Siemens Medical Solutions USA, Inc. — 13 clearances
- Brainlab AG — 11 clearances
- Computerized Medical Systems, Inc. — 9 clearances
