510(k) Report

Devices descending from K031349

59 later devices reach OTP 1.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation2008542
+1K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+2K121448Oncentra, Oncentra External Beam, Oncentra BrachyElekta Inc. D/B/A Nucletron Corporation201293
+2K100552Raystation Version 1.0Raysearch Laboratories AB2010304
+2K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+2K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+2K083264Rayautoplan 1.0Raysearch Laboratories AB2009312
+2K082642Oncentra RT Viewer 1.0Nucletron Corporation20080—
+3K132816Oncentra BrachyNucletron B.V.201403
+3K132971MonacoImpac Medical Systems, Inc.201374
+3K120387RaystationRaysearch Laboratories AB2012226
+3K112060RadianceGmv Aerospace and Defence S.A.20126—
+3K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+3K103093Leksell GammaplanElekta Instrument AB201051
+3K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+3K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+4K193459Panther StereotacticProwess, Inc.20201—
+4K151666Leksell GammaPlanElekta Instrument AB201541
+4K151233MonacoImpac Medical Systems, Inc.201569
+4K140187Ray StationRaysearch Laboratories AB2014191
+4K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+4K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+4K130617RaystationRaysearch Laboratories AB2013216
+5K231825Panther TPSProwess, Inc.20230—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K173940Astroid Planning App.Decimal, LLC20180—
+5K173791Leksell GammaPlanElekta Instrument AB201832
+5K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+5K151435MRCATPhilips Medical Systems MR Finland20164—
+5K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+5K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+5K141860RaystationRaysearch Laboratories AB2014175
+6K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+6K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+6K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+7K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+7K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+7K180308PreludeMedcom GmbH20180—
+7K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+8K211841MRI PlannerSpectronic Medical AB20220—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K214081MRCAT Head & NeckPhilips OY20220—
+8K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+8K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+9K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+10K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+11K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+12K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+13K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+14K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+15K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+16K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+17K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—