510(k) Report

Devices descending from K010975

108 later devices reach Eclipse 6.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030981EclipseVarian Medical Systems, Inc.2003107—
+2K041937RestituResonant Medical, Inc.20043—
+2K041403Eclipse with AaaVarian Medical Systems2004102—
+3K111332Clarity Obp SystemElekta, Ltd.20122—
+3K050296Eclipse Treatment Planning SystemVarian Medical Systems2005101—
+4K121663ClarityElekta, Ltd.20121—
+4K071760Modification to: Eclipse Treatment Planning SystemVarian Medical Systems, Inc.200735—
+4K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2007945
+5K141855ClarityElekta, Ltd.20140—
+5K112778Smart Segmentation-Knowledge Based ContouringVarian Medical Systems20115—
+5K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+5K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2007926
+6K133227Smart Segmentation - Knowledge Based ContouringVarian Medical Systems, Inc.20144—
+6K103093Leksell GammaplanElekta Instrument AB201051
+6K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+6K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+6K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2009872
+7K151666Leksell GammaPlanElekta Instrument AB201541
+7K141248Smart Segmentation Knowledge Based ContouringVarian Medical Systems, Inc.20143—
+7K140187Ray StationRaysearch Laboratories AB2014191
+7K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+7K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+7K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+7K102011Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2010585
+7K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+7K092928Dose Volume Histogram (DVH) EvaluatorDiversilabs, LLC20090—
+8K212274INT ContourCarina Medical, LLC20220—
+8K203469AI SegmentationVarian Medical Systems, Inc.20211—
+8K193459Panther StereotacticProwess, Inc.20201—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K173940Astroid Planning App.Decimal, LLC20180—
+8K173791Leksell GammaPlanElekta Instrument AB201832
+8K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+8K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+8K151435MRCATPhilips Medical Systems MR Finland20164—
+8K141860RaystationRaysearch Laboratories AB2014175
+8K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+8K132971MonacoImpac Medical Systems, Inc.201374
+8K131891Eclipse Treatment Planning SystemVarian Medical Systems, Inc.201337—
+9K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+9K231825Panther TPSProwess, Inc.20230—
+9K211881AI SegmentationVarian Medical Systems, Inc.20210—
+9K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K181989MRIdian Linac SystemViewray, Incorporated201912
+9K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated201774
+9K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+9K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+9K151233MonacoImpac Medical Systems, Inc.201569
+9K141283Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2014351
+9K133247Eclipse Treatment Planning SystemVarian Medical Systems, Inc.201436—
+10K213526Aurora-RTMagnettx Oncology Solutions, Ltd.20220—
+10K212958MRIdian Linac SystemViewray, Incorporated20210—
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+10K182076Elekta UnityElekta Limited201834
+10K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+10K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+10K152393Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2015331
+10K151560QuickPlanSiris Medical20150—
+11K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+11K211841MRI PlannerSpectronic Medical AB20220—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+11K214081MRCAT Head & NeckPhilips OY20220—
+11K192482Elekta UnityElekta Limited201923
+11K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+11K180308PreludeMedcom GmbH20180—
+11K171352EZFluenceRadformation, Inc.20171—
+11K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+11K170969Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2017301
+11K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+12K261718EZFluence (RADEZ V2)Radformation, Inc.20260—
+12K223233Monaco RTP SystemElekta Solutions AB20231—
+12K212114Elekta UnityElekta Solutions AB202111
+12K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+12K172163Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2017291
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+13K223724Mozi TPSManteia Technologies Co., Ltd.20230—
+13K223209Elekta UnityElekta Solutions AB20230—
+13K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+13K181145Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2018261
+14K222728Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer Center20232—
+14K221448ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)Varian Medical Systems, Inc.20220—
+14K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+14K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+14K200608Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc.20205—
+14K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+15K242822ART-Plan+ (v.3.0.0)Therapanacea Sas20251—
+15K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+15K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+15K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+15K201607Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc.20204—
+16K253091ART-Plan+ (v3.1.0)Therapanacea Sas20250—
+16K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+16K232479ART-PlanTherapanacea20232—
+16K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+16K230557Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc.20233—
+16K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+17K253078ART.1-USSeetreat Pty, Ltd.20260—
+17K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—