510(k) Report

Devices descending from K911612

93 later devices reach Nucletron Planning System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992303Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp.20006—
+1K983343Plato Brachytheraphy, Model V. 14.0Nucletron Corp.199985—
+2K121448Oncentra, Oncentra External Beam, Oncentra BrachyElekta Inc. D/B/A Nucletron Corporation201293
+2K113102Oncentra Manual Low Dose Rate Treatment PlanningNucletron20110—
+2K081112Flexiplan Brachytherapy Treatment Planning SystemIsodose Control B.V.20083—
+2K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation2008542
+2K061152Mucheck V7.0Oncology Data Systems, Inc.200621—
+2K030821Simuplan Treatment Planning System, Model V. 7.5Simuplan S.L.20032—
+2K022739Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002Nucletron Corporation20024—
+2K022741Spot Pro (220V), Model 131.099Nucletron Corporation20022—
+3K132816Oncentra BrachyNucletron B.V.201403
+3K132971MonacoImpac Medical Systems, Inc.201374
+3K112420Oncentra Prostate 4.0Nucletron20111—
+3K100552Raystation Version 1.0Raysearch Laboratories AB2010304
+3K093391Simuplan Treatment Planning SystemSimuplan S.L.20091—
+3K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+3K091602Mucheck V8Oncology Data Systems, Inc.20091—
+3K090531Radcalc Software, Version 6.0Lifeline Software, Inc.200917—
+3K091145Flexiplan 3D and 3D+Isodose Control B.V.20092—
+3K083264Rayautoplan 1.0Raysearch Laboratories AB2009312
+3K082773Standard Imaging Imsure Brachy QA Software, Model 91331Standard Imaging, Inc.20080—
+3K082642Oncentra RT Viewer 1.0Nucletron Corporation20080—
+3K031158Swift 2.0, Model 132.001Nucletron Corp.20033—
+4K193640ClearCalcRadformation, Inc.20202—
+4K170841BiopSee, Mobile USMedcom GmbH20170—
+4K153014Mobius3DMobius Medical Systems, LP201613—
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K123263Hdrplus, Add in Prostate Module for HdrplusEckert & Ziegler Bebig GmbH20131—
+4K120551Simuplan Treatment Planning SystemSimuplan S.L.20120—
+4K120387RaystationRaysearch Laboratories AB2012226
+4K112060RadianceGmv Aerospace and Defence S.A.20126—
+4K103093Leksell GammaplanElekta Instrument AB201051
+4K102583Mucheck, Version 9.0Oncology Data Systems, Inc.20100—
+4K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+4K080929Oncentra GynNucletron Corporation20080—
+5K220582ClearCalc Model RADCA V2Radformation, Inc.20221—
+5K201798myQA iONIba Dosimetry GmbH202011
+5K191761Mobius3DVarian Medical Systems, Inc.20195—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K171350Collision CheckRadformation, Inc.20174—
+5K151666Leksell GammaPlanElekta Instrument AB201541
+5K141900Sagiplan, Sagiplan Prostate Module Add on, Sagiplan Including Prostate ModuleEckert & Ziegler Bebig GmbH201501
+5K140187Ray StationRaysearch Laboratories AB2014191
+5K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+5K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+5K130617RaystationRaysearch Laboratories AB2013216
+6K260597Virtue QAProNova Solutions20260—
+6K252863ClearCalc Model RADCA V2.6Radformation, Inc.20250—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K192424Mobius3DVarian Medical Systems, Inc.20194—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K173940Astroid Planning App.Decimal, LLC20180—
+6K173791Leksell GammaPlanElekta Instrument AB201832
+6K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+6K151435MRCATPhilips Medical Systems MR Finland20164—
+6K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+6K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+6K141860RaystationRaysearch Laboratories AB2014175
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+7K231185MapRTVision Rt, Ltd.20231—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K203669Mobius3DVarian Medical Systems, Inc.20213—
+7K193459Panther StereotacticProwess, Inc.20201—
+7K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+7K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+7K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+8K243301MapRTVision Rt, Ltd.20250—
+8K250099Mobius3D (4.1)Varian Medical Systems20250—
+8K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+8K231825Panther TPSProwess, Inc.20230—
+8K223834AccuCheckManteia Technologies Co., Ltd.20231—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+8K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+8K180308PreludeMedcom GmbH20180—
+8K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+9K250696AccuCheckManteia Technologies Co., Ltd.20250—
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+9K211841MRI PlannerSpectronic Medical AB20220—
+9K214081MRCAT Head & NeckPhilips OY20220—
+9K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+9K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+10K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+11K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+12K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+13K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+14K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+15K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+16K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+17K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+18K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—