Product Code: MUJ FDA class 2 21 CFR 892.5050

System, Planning, Radiation Therapy Treatment

Radiology

A Radiation Therapy Treatment Planning System is a software-based medical device used to design individualized radiation therapy plans for cancer patients, calculating optimal beam arrangements, dose distributions, and treatment parameters to target tumors while minimizing radiation exposure to surrounding healthy tissues. It is FDA Class 2, requiring 510(k) clearance, with product code MUJ under 21 CFR 892.5050 in the Radiology specialty. The device is not an implant and is not life-sustaining.

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510(k)s

256

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MUJ
Device Class: FDA class 2
Regulation Number: 892.5050
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 256 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253050	RadOncAI	Jun 18, 2026	Substantially Equivalent	Informai
K260207	Multimodality Simulation Workspace (MM Sim) (v1.0.0)	May 27, 2026	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K252784	eXaSkin Plus	May 22, 2026	Substantially Equivalent	Anatomical Geometry S.L.
K253078	ART.1-US	May 14, 2026	Substantially Equivalent	Seetreat Pty, Ltd.
K252304	syngo.via RT Image Suite VC10	Mar 18, 2026	Substantially Equivalent	Varian Medical Systems, Inc.
K260308	TrueFit Bolus	Feb 19, 2026	Substantially Equivalent	Adaptiiv Medical Technologies, Inc.
K252002	Monaco RTP System (6.3)	Feb 19, 2026	Substantially Equivalent	Elekta Solutions AB
K253091	ART-Plan+ (v3.1.0)	Dec 23, 2025	Substantially Equivalent	Therapanacea Sas
K252109	RayStation (2024A SP3)	Dec 22, 2025	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K252863	ClearCalc Model RADCA V2.6	Dec 19, 2025	Substantially Equivalent	Radformation, Inc.
K250963	PlanOne 1	Nov 20, 2025	Substantially Equivalent	Cosylab Jsc, Control System Laboratory
K250064	Dose+ (1.0)	Sep 04, 2025	Substantially Equivalent	Mvision AI OY
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	Jun 17, 2025	Substantially Equivalent	Brainlab AG
K242992	RayCare (2024A SP1)	Apr 17, 2025	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K242748	Oncospace	Apr 11, 2025	Substantially Equivalent	Oncospace, Inc.
K240398	RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3	Apr 04, 2025	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K242822	ART-Plan+ (v.3.0.0)	Feb 25, 2025	Substantially Equivalent	Therapanacea Sas
K242463	ARIA Radiation Therapy Management System (18.1)	Dec 13, 2024	Substantially Equivalent	Varian Medical Systems, Inc.
K242378	Eclipse Treatment Planning System (18.1)	Dec 11, 2024	Substantially Equivalent	Varian Medical Systems
K240671	XBeam (v2)	Dec 04, 2024	Substantially Equivalent	Xstrahl, Ltd.
K243057	TrueFit Bolus; TrueFlex Bolus	Oct 23, 2024	Substantially Equivalent	Adaptiiv Medical Technologies, Inc.
K241876	Vitesse (5.0)	Oct 23, 2024	Substantially Equivalent	Varian Medical Systems
K241318	Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)	Aug 30, 2024	Substantially Equivalent	Adaptiiv Medical Technologies, Inc.
K233236	Radiance V5	May 17, 2024	Substantially Equivalent	Gmv Soluciones Globales Internet S.A.U.
K232799	syngo.via RT Image Suite	Apr 26, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K234068	ART-Plan (v.2.2.0)	Apr 22, 2024	Substantially Equivalent	Therapanacea Sas
K232479	ART-Plan	Dec 22, 2023	Substantially Equivalent	Therapanacea
K231825	Panther TPS	Dec 15, 2023	Substantially Equivalent	Prowess, Inc.
K232400	VariSeed (v10)	Sep 08, 2023	Substantially Equivalent	Varian Medical Systems
K223724	MOZI TPS	Jul 10, 2023	Substantially Equivalent	Manteia Technologies Co., Ltd.
K230557	Eclipse Treatment Planning System (v18.0)	May 26, 2023	Substantially Equivalent	Varian Medical Systems, Inc.
K222728	Radiation Planning Assistant (RPA)	May 17, 2023	Substantially Equivalent	University of Texas, MD Anderson Cancer Center
K222312	RayStation 12A	Mar 29, 2023	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K223279	RT Elements (4.0)	Mar 14, 2023	Substantially Equivalent	Brainlab AG
K223233	Monaco RTP System	Feb 23, 2023	Substantially Equivalent	Elekta Solutions AB
K222803	Oncospace	Feb 02, 2023	Substantially Equivalent	Oncospace, Inc.
K220783	syngo.via RT Image Suite	Sep 07, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K211841	MRI Planner	Aug 25, 2022	Substantially Equivalent	Spectronic Medical AB
K220582	ClearCalc Model RADCA V2	Aug 22, 2022	Substantially Equivalent	Radformation, Inc.
K213787	Monaco RTP System	May 17, 2022	Substantially Equivalent	Elekta Solutions AB
K220141	RayStation 11B	Apr 15, 2022	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K212274	INT Contour	Apr 08, 2022	Substantially Equivalent	Carina Medical, LLC
K214081	MRCAT Head & Neck	Apr 05, 2022	Substantially Equivalent	Philips OY
K213438	3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory	Jan 19, 2022	Substantially Equivalent	Adaptiiv
K211867	RayStation 11.0	Sep 08, 2021	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K211881	AI Segmentation	Sep 02, 2021	Substantially Equivalent	Varian Medical Systems, Inc.
K211379	syngo.via RT Image Suite	Jul 30, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K211511	decimal Bolus	Jul 01, 2021	Substantially Equivalent	.Decimal, LLC
K210645	RayStation 10.1	Jun 29, 2021	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K211034	Corvus Radiation Therapy Planning System	May 06, 2021	Substantially Equivalent	Best Nomos
K203469	AI Segmentation	Apr 19, 2021	Substantially Equivalent	Varian Medical Systems, Inc.
K203681	RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review	Apr 09, 2021	Substantially Equivalent	Brainlab AG
K202284	Oncospace	Mar 12, 2021	Substantially Equivalent	Oncospace, Inc.
K202789	Monaco Rtp System	Feb 23, 2021	Substantially Equivalent	Elekta Solutions AB
K203766	4D Integrated Treatment Console	Feb 12, 2021	Substantially Equivalent	Varian Medical Systems, Inc.
K200569	RayStation	Sep 24, 2020	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K201350	CORVUS	Sep 20, 2020	Substantially Equivalent	Best Nomos
K201444	Syngo.via RT Image Suite	Aug 13, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K201607	Eclipse Treatment Planning System v16.1	Jul 10, 2020	Substantially Equivalent	Varian Medical Systems, Inc.
K200487	RayCare 3.1	Jun 10, 2020	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K193459	Panther Stereotactic	Apr 27, 2020	Substantially Equivalent	Prowess, Inc.
K193640	ClearCalc	Apr 09, 2020	Substantially Equivalent	Radformation, Inc.
K200608	Eclipse Treatment Planning System v16.0	Apr 03, 2020	Substantially Equivalent	Varian Medical Systems, Inc.
K193109	MRCAT brain	Jan 24, 2020	Substantially Equivalent	Philips Medical Systems MR Finland
K193381	RadCalc Software	Dec 31, 2019	Substantially Equivalent	Lifeline Software, Inc.
K192554	decimal3D	Dec 13, 2019	Substantially Equivalent	.Decimal, LLC
K192065	Syngo.Via RT Image Suite	Sep 18, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K191384	RayCare 2.3	Jul 08, 2019	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K190387	RayStation	Jun 19, 2019	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K182888	MRCAT Pelvis	Apr 30, 2019	Substantially Equivalent	Philips Medical Systems MR Finland
K190664	RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review	Apr 12, 2019	Substantially Equivalent	Brainlab AG
K190178	Monaco RTP System	Mar 29, 2019	Substantially Equivalent	Elekta, Inc.
K182665	Sensus TPS Workstation	Feb 21, 2019	Substantially Equivalent	Sensus Healthcare, Inc.
K183037	Monaco RTP System	Dec 04, 2018	Substantially Equivalent	Elekta, Inc.
K180289	3D Bolus Software	Jul 10, 2018	Substantially Equivalent	3D Bolus, Inc.
K181145	Eclipse Treatment Planning System	May 18, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K173940	Astroid Planning App	May 15, 2018	Substantially Equivalent	.Decimal, LLC
K180379	RayStation 7	Apr 25, 2018	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K180308	Prelude	Mar 27, 2018	Substantially Equivalent	Medcom GmbH
K173635	syngo.via RT Image Suite	Jan 12, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K170750	RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review	Aug 24, 2017	Substantially Equivalent	Brainlab AG
K172163	Eclipse Treatment Planning System	Aug 15, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K171885	Radiance V4	Jul 25, 2017	Substantially Equivalent	Gmv Soluciones Globales Internet S.A.U.
K170969	Eclipse Treatment Planning System	Jul 05, 2017	Substantially Equivalent	Varian Medical Systems, Inc.
K171536	RayStation	Jun 27, 2017	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K170355	RayStation 6	Mar 02, 2017	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K170086	Pinnacle Radiation Therapy Planning System	Feb 09, 2017	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K162370	syngo.via RT Image Suite	Oct 25, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161136	Precision Treatment Planning System	Jun 24, 2016	Substantially Equivalent	Accuray Incorporated
K160093	RayStation	Apr 08, 2016	Substantially Equivalent	RaySearch Laboratories AB (PUBL)
K151435	MRCAT	Feb 25, 2016	Substantially Equivalent	Philips Medical Systems MR Finland
K153368	Radiance V3	Feb 16, 2016	Substantially Equivalent	Gmv Soluciones Globales Internet S.A.U.
K143514	Panther StereoSeed	Dec 11, 2015	Substantially Equivalent	Prowess, Inc.
K151469	CORVUS Radiation Therapy Planning System	Nov 25, 2015	Substantially Equivalent	Best Nomos
K152488	Onrad Treatment System	Sep 28, 2015	Substantially Equivalent	Accuray Incorporated
K152393	Eclipse Treatment Planning System	Sep 18, 2015	Substantially Equivalent	Varian Medical Systems, Inc.
K151887	syngo VSim	Sep 16, 2015	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K151560	QuickPlan	Sep 11, 2015	Substantially Equivalent	Siris Medical
K151666	Leksell GammaPlan	Sep 03, 2015	Substantially Equivalent	Elekta Instrument AB
K151380	syngo.via RT Image Suite	Aug 13, 2015	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K151369	.decimal p.d	Aug 07, 2015	Substantially Equivalent	.Decimal, LLC
K151233	Monaco	Jul 07, 2015	Substantially Equivalent	Impac Medical Systems, Inc.
K141900	SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE	May 20, 2015	Substantially Equivalent	Eckert & Ziegler Bebig GmbH
K150547	.decimal Astroid Dosimetry App	May 15, 2015	Substantially Equivalent	.Decimal, Inc.
K143269	Delivery Analysis	Apr 14, 2015	Substantially Equivalent	Accuray Incorporated
K142108	RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS	Dec 16, 2014	Substantially Equivalent	Brainlab AG
K141860	RAYSTATION	Oct 23, 2014	Substantially Equivalent	Raysearch Laboratories AB
K141248	SMART SEGMENTATION KNOWLEDGE BASED CONTOURING	Sep 05, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K141283	ECLIPSE TREATMENT PLANNING SYSTEM	Aug 07, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K132816	ONCENTRA BRACHY	Jun 13, 2014	Substantially Equivalent	Nucletron B.V.
K140187	RAY STATION	May 15, 2014	Substantially Equivalent	Raysearch Laboratories AB
K133247	ECLIPSE TREATMENT PLANNING SYSTEM	Feb 07, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K133655	RADIANCE V2	Jan 31, 2014	Substantially Equivalent	Gmv Soluciones Globales Internet S.A.U.
K133331	4D INTEGRATED TREATMENT CONSOLE	Jan 27, 2014	Substantially Equivalent	Varian Medical Systems, Inc.
K132971	MONACO	Nov 20, 2013	Substantially Equivalent	Impac Medical Systems, Inc.
K131891	ECLIPSE TREATMENT PLANNING SYSTEM	Sep 25, 2013	Substantially Equivalent	Varian Medical Systems, Inc.
K131428	RADVISION	Jul 16, 2013	Substantially Equivalent	Acoustic Medsystems, Inc.
K130617	RAYSTATION	May 10, 2013	Substantially Equivalent	Raysearch Laboratories AB
K123263	HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS	Apr 04, 2013	Substantially Equivalent	Eckert & Ziegler Bebig GmbH
K123357	ONQ RTS	Dec 28, 2012	Substantially Equivalent	Oncology Systems, Inc.
K123152	VITESSE 3.0	Dec 07, 2012	Substantially Equivalent	Varian Medical Systems, Oncology Systems
K121448	ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY	Jul 02, 2012	Substantially Equivalent	Elekta Inc. D/B/A Nucletron Corporation
K120551	SIMUPLAN TREATMENT PLANNING SYSTEM	Jun 08, 2012	Substantially Equivalent	Simuplan S.L.
K120387	RAYSTATION	Apr 06, 2012	Substantially Equivalent	Raysearch Laboratories AB
K120363	SYNGO RT INTERFACE	Mar 20, 2012	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K112723	EPIGRAY	Feb 08, 2012	Substantially Equivalent	Dosisoft SA
K112060	RADIANCE	Jan 06, 2012	Substantially Equivalent	Gmv Aerospace and Defence S.A.
K112776	TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER	Dec 22, 2011	Substantially Equivalent	Tomotherapy Incorporated
K113102	ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING	Dec 12, 2011	Substantially Equivalent	Nucletron
K111311	SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING	Oct 17, 2011	Substantially Equivalent	Omisa Inc. (Segasist Technologies)
K112446	TOMOTHERAPY TREATMENT SYSTEM	Oct 07, 2011	Substantially Equivalent	Tomotherapy Incorporated
K103515	EQUAL DOSE	Sep 15, 2011	Substantially Equivalent	Nucletron Corporation
K110730	MONACO RTP SYSTEM	Jun 24, 2011	Substantially Equivalent	Computerized Medical Systems, Inc.
K103246	IPLAN RT	Mar 16, 2011	Substantially Equivalent	Brainlab AG
K103146	ISOGRAY TREATMENT PLANNING SYSTEM	Mar 11, 2011	Substantially Equivalent	Dosisoft SA
K102915	VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM	Jan 12, 2011	Substantially Equivalent	Viewray, Incorporated
K103093	LEKSELL GAMMAPLAN	Dec 21, 2010	Substantially Equivalent	Elekta Instrument AB
K101220	EXPLORER 4D TREATMENT PLANNING SYSTEM	Nov 05, 2010	Substantially Equivalent	American Radiosurgery, Inc.
K102216	XIO RTP SYSTEM	Oct 01, 2010	Substantially Equivalent	Computerized Medical Systems, Inc.
K102011	ECLIPSE TREATMENT PLANNING SYSTEM	Sep 03, 2010	Substantially Equivalent	Varian Medical Systems, Inc.
K101076	PROWESS PANTHER PROARC, MODEL VERSION 5.0	Jul 27, 2010	Substantially Equivalent	Prowess, Inc.
K101119	SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864	Jun 16, 2010	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K100056	MEDCOM RT-VIEWER SYSTEM	May 07, 2010	Substantially Equivalent	Medcom GmbH
K100417	XKNIFE 5	Apr 08, 2010	Substantially Equivalent	Integra Radionics, Inc.
K100552	RAYSTATION VERSION 1.0	Mar 12, 2010	Substantially Equivalent	Raysearch Laboratories AB
K100092	CORVUS RADIATION THERAPY PLANNING SYSTEM	Feb 23, 2010	Substantially Equivalent	Best Nomos
K093588	EXPLORER 4D TREATMENT PLANNING SYSTEM	Jan 11, 2010	Substantially Equivalent	American Radiosurgery, Inc.
K093391	SIMUPLAN TREATMENT PLANNING SYSTEM	Dec 23, 2009	Substantially Equivalent	Simuplan S.L.
K092928	DOSE VOLUME HISTOGRAM (DVH) EVALUATOR	Dec 16, 2009	Substantially Equivalent	Diversilabs, LLC
K092132	XIO RTP SYSTEM	Sep 24, 2009	Substantially Equivalent	Computerized Medical Systems, Inc.
K090972	LEKSELL GAMMAPLAN	Jul 20, 2009	Substantially Equivalent	Elekta Instrument AB
K091179	MONACO RTP SYSTEM, VMAT OPTION	Jul 16, 2009	Substantially Equivalent	Computerized Medical Systems, Inc.
K090893	TIGRT TPS	Jul 15, 2009	Substantially Equivalent	Linatech, LLC
K091492	MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM	Jun 18, 2009	Substantially Equivalent	Varian Medical Systems, Inc.
K091145	FLEXIPLAN 3D AND 3D+	May 27, 2009	Substantially Equivalent	Isodose Control B.V.
K090531	RADCALC SOFTWARE, VERSION 6.0	May 27, 2009	Substantially Equivalent	Lifeline Software, Inc.
K083502	PANTHER REALART, MODEL 4.7	May 05, 2009	Substantially Equivalent	Prowess, Inc.
K090182	MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)	May 04, 2009	Substantially Equivalent	Nuclemed S.A.
K091146	MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	May 01, 2009	Substantially Equivalent	Accuray, Inc.
K083672	P.D SOFTWARE	Apr 13, 2009	Substantially Equivalent	.Decimal, Inc.
K090808	PINNACLE3 SMARTARC	Apr 03, 2009	Substantially Equivalent	Philips Medical Systems, Inc.
K083414	RADIONICS XKNIFE HDRT SYSTEM	Mar 02, 2009	Substantially Equivalent	Integra Radionics, Inc.
K083264	RAYAUTOPLAN 1.0	Jan 22, 2009	Substantially Equivalent	Raysearch Laboratories AB
K082606	COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)	Nov 10, 2008	Substantially Equivalent	D3 Radiation Planning
K082642	ONCENTRA RT VIEWER 1.0	Nov 07, 2008	Substantially Equivalent	Nucletron Corporation
K082221	RAYDOSE	Oct 22, 2008	Substantially Equivalent	Raysearch Laboratories AB
K082005	MODIFICATION TO HI-ART TREATMENT SYSTEM	Aug 25, 2008	Substantially Equivalent	Tomotherapy Incorporated
K081112	FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM	Jul 29, 2008	Substantially Equivalent	Isodose Control B.V.
K080888	MODEIFICATION TO IPLAN RT DOSE	Jun 11, 2008	Substantially Equivalent	Brainlab AG
K080601	ERGO++ VERSION 1.7	Jun 06, 2008	Substantially Equivalent	3D Line Medical Systems S.R.L.
K081281	OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)	May 20, 2008	Substantially Equivalent	Nucletron Corporation
K080929	ONCENTRA GYN	Apr 16, 2008	Substantially Equivalent	Nucletron Corporation
K073020	ECLIPSE TREATMENT PLANNING SYSTEM	Dec 19, 2007	Substantially Equivalent	Varian Medical Systems, Inc.
K071760	MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM	Nov 09, 2007	Substantially Equivalent	Varian Medical Systems, Inc.
K071938	MONACO RTP SYSTEM	Oct 01, 2007	Substantially Equivalent	Computerized Medical Systems, Inc.
K071873	MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM	Aug 09, 2007	Substantially Equivalent	Varian Medical Systems, Inc.
K063230	INTEGRA RADIONICS IMAGEFUSION 3	Dec 21, 2006	Substantially Equivalent	Integra Radionics, Inc.
K063482	CROSSPLAN / ACCUSOFT-XL V.4.04	Dec 14, 2006	Substantially Equivalent	Direx Systems Corp.
K062967	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Oct 30, 2006	Substantially Equivalent	Accuray, Inc.
K062032	ACCUSOFT, ACCUSOFT XL	Oct 05, 2006	Substantially Equivalent	Direx Systems Corp.
K062514	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Sep 28, 2006	Substantially Equivalent	Accuray Incorporated
K061893	INTEGRA RADIONICS XKNIFE RT 4	Jul 25, 2006	Substantially Equivalent	Integra Radionics, Inc.
K053584	IPLAN RT DOSE	Jul 12, 2006	Substantially Equivalent	Brainlab AG
K061440	P.D	Jun 27, 2006	Substantially Equivalent	.Decimal, Inc.
K061097	COHERENCE DOSIMETRIST, MODEL 2.2	Jun 07, 2006	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K050296	ECLIPSE TREATMENT PLANNING SYSTEM	Nov 03, 2005	Substantially Equivalent	Varian Medical Systems
K052325	CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY	Sep 14, 2005	Substantially Equivalent	Accuray Incorporated
K051941	CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM	Aug 09, 2005	Substantially Equivalent	Accuray, Inc.
K051497	VITESSE 2.0	Jul 18, 2005	Substantially Equivalent	Varian Medical Systems, Inc.
K041971	WIMRT MODULE FOR ARTP PLANNING SYSTEM	May 20, 2005	Substantially Equivalent	Prodigm Group, Inc.
K042861	ODYSSEY	Jan 12, 2005	Substantially Equivalent	Permedics, Inc.
K042739	HI-ART SYSTEM	Nov 03, 2004	Substantially Equivalent	Tomotherapy Incorporated
K042269	LEKSELL GAMMAPLAN 4C WITH MULTIVIEW	Sep 08, 2004	Substantially Equivalent	Elekta Instrument AB
K041997	RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE	Aug 27, 2004	Substantially Equivalent	Radionics, A Division of Tyco Healthcare Group LP
K041403	ECLIPSE WITH AAA	Jul 26, 2004	Substantially Equivalent	Varian Medical Systems
K031088	TRIMED PLAN, VERSION 2.2	Jul 23, 2004	Substantially Equivalent	Trimed Systems, Inc.
K041719	ONCENTRA-VISIR	Jul 22, 2004	Substantially Equivalent	Nucletron Corp.
K040474	ACCUSOFT	Jun 23, 2004	Substantially Equivalent	Direx Systems Corp.
K040688	STANDARD IMAGING E.IMRT CALCULATOR	May 11, 2004	Substantially Equivalent	Standard Imaging, Inc.
K031281	ERGO SRS	Dec 23, 2003	Substantially Equivalent	3D Line USA, Inc.
K032456	PROWESS	Oct 16, 2003	Substantially Equivalent	Prowess, Inc.
K032724	PINNACLE3 RADIATION THERAPY PLANNING SYSTEM	Oct 09, 2003	Substantially Equivalent	Adac Laboratories
K030821	SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5	Sep 17, 2003	Substantially Equivalent	Simuplan S.L.
K032345	CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY	Sep 03, 2003	Substantially Equivalent	Accuray, Inc.
K032209	NOMOS CORVUS 5.0M	Aug 21, 2003	Substantially Equivalent	Nomos Corp.
K031349	OTP 1.2	Aug 07, 2003	Substantially Equivalent	Nucletron Corp.
K022961	RTDOSEPLAN	Jan 31, 2003	Substantially Equivalent	Math Resolutions, LLC
K022036	SIEMENS VIRTUAL SIMULATION (VSIM)	Nov 05, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K022741	SPOT PRO (220V), MODEL 131.099	Oct 24, 2002	Substantially Equivalent	Nucletron Corporation
K022307	KONRAD, MODEL V.2.0	Oct 08, 2002	Substantially Equivalent	Mrc Systems GmbH
K020027	FOCUS RADIATION TREATMENT PLANNING SYSTEM	Oct 08, 2002	Substantially Equivalent	Computerized Medical Systems, Inc.
K022411	PRECISEPLAN 2.0	Sep 20, 2002	Substantially Equivalent	Precision Therapy Intl., Inc.
K013644	ACQPLAN 5.0	Sep 12, 2002	Substantially Equivalent	Philips Medical Systems, Inc.
K020971	DCM 2.0	Jun 06, 2002	Substantially Equivalent	Mds Nordion AB
K021268	ECLIPSE, HELIOS OPTION	May 22, 2002	Substantially Equivalent	Varian Medical Systems, Inc.
K012575	PREFERNCE IMRT TREATMENT PLANNING MODULE	Mar 12, 2002	Substantially Equivalent	Northwest Medical Physics Equipment, Inc.
K013673	HI-ART SYSTEM	Jan 28, 2002	Substantially Equivalent	Tomo Therapy, Inc.
K013535	EVTOOL MODEL # V. 1.0	Jan 18, 2002	Substantially Equivalent	3D Line USA, Inc.
K013112	FOCAL SIM	Dec 05, 2001	Substantially Equivalent	Computerized Medical Systems, Inc.
K013661	XPLAN 2.2 WITH THE BODY SYSTEM	Dec 03, 2001	Substantially Equivalent	Radionics, A Division of Tyco Healthcare Group LP
K002132	ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS	Oct 18, 2001	Substantially Equivalent	Intelligent Instruments Pvt. , Ltd.
K012017	VARISEED 7.0	Jul 12, 2001	Substantially Equivalent	Varian Medical Systems
K010682	HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM	Jun 05, 2001	Substantially Equivalent	Mds Nordion
K011246	DCM 1.0	May 23, 2001	Substantially Equivalent	Mds Nordion
K010784	PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1	Apr 10, 2001	Substantially Equivalent	Nucletron Corp.
K002237	P3IMRT TM	Feb 02, 2001	Substantially Equivalent	Adac Laboratories
K002509	NOVALIS (SHAPED BEAM SURGERY SYSTEM)	Nov 03, 2000	Substantially Equivalent	Brainlab AG
K001295	PIPER	Oct 25, 2000	Substantially Equivalent	Rtek Medical Systems, LLC
K002147	FOCUS	Oct 13, 2000	Substantially Equivalent	Computerized Medical Systems, Inc.
K993675	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	Sep 05, 2000	Substantially Equivalent	Nomos Corp.
K002312	PROTON VISION 7.0	Aug 30, 2000	Substantially Equivalent	Varian Medical Systems, Inc.
K002240	RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0	Aug 23, 2000	Substantially Equivalent	Precision Therapy Intl., Inc.
K994413	BRAINSCAN	Jul 13, 2000	Substantially Equivalent	Brainlab AG
K001700	XPLAN 2.1	Jun 28, 2000	Substantially Equivalent	Radionics, Inc.
K993895	OPTIRAD	Jun 02, 2000	Substantially Equivalent	Permedics, Inc.
K000922	PROTON VISION	May 24, 2000	Substantially Equivalent	Varian Assoc., Inc.
K993923	ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM	Apr 07, 2000	Substantially Equivalent	Adac Laboratories
K992303	SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0	Mar 27, 2000	Substantially Equivalent	Nucletron Corp.
K992762	BRACHYVISION 6.0	Mar 09, 2000	Substantially Equivalent	Varian Assoc., Inc.
K992434	ITP, MODEL 1.0	Jan 13, 2000	Substantially Equivalent	Nucletron Corp.
K993766	HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM	Dec 08, 1999	Substantially Equivalent	Helax AB
K990475	TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5	Nov 18, 1999	Substantially Equivalent	Kps & Assoc., Inc.
K992864	RENDER-PLAN 3-D	Sep 09, 1999	Substantially Equivalent	Precision Therapy Intl., Inc.
K992753	CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM	Sep 03, 1999	Substantially Equivalent	Varian Assoc., Inc.
K991237	XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL	Aug 30, 1999	Substantially Equivalent	Radionics, Inc.
K991815	EXPLORER 3D	Aug 13, 1999	Substantially Equivalent	Our Scientific Intl., Inc.
K984532	CADPLAN HELIOS OPTION 6.0	Aug 09, 1999	Substantially Equivalent	Varian Medical Systems, Inc.
K983343	PLATO BRACHYTHERAPHY, MODEL V. 14.0	Apr 02, 1999	Substantially Equivalent	Nucletron Corp.
K982696	INTERPLANT	Apr 01, 1999	Substantially Equivalent	Burdette Medical Systems, Inc.
K990071	IMAGEFUSION 2.0	Feb 08, 1999	Substantially Equivalent	Radionics, Inc.
K982791	ROCS TPS	Dec 30, 1998	Substantially Equivalent	Radiation Oncology Computer Systems
K984196	MODIFICATION TO PROWESS PRO-SIM	Dec 11, 1998	Substantially Equivalent	Ssgi Prowess Systems
K981678	STRATA, MODEL V.O.95	Dec 11, 1998	Substantially Equivalent	Rosses Medical Systems
K982821	MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7	Nov 05, 1998	Substantially Equivalent	Multimedia Medical Systems, Inc.
K974770	ACQPLAN	Sep 02, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K915691	FOCUS RTP	Feb 16, 1995	Substantially Equivalent	Computerized Medical Systems, Inc.