510(k) Report

Devices descending from K032762

52 later devices reach Xio Radiation Treatment Planning System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+1K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+1K061440P.D.Decimal, Inc.20068—
+2K103093Leksell GammaplanElekta Instrument AB201051
+2K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+2K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+2K083672P.D Software.Decimal, Inc.20097—
+3K151666Leksell GammaPlanElekta Instrument AB201541
+3K151369.decimal p.d.Decimal, LLC20156—
+3K140187Ray StationRaysearch Laboratories AB2014191
+3K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+3K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+3K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+4K193459Panther StereotacticProwess, Inc.20201—
+4K192554decimal3D.Decimal, LLC20190—
+4K1802893D Bolus Software3D Bolus, Inc.20184—
+4K173940Astroid Planning App.Decimal, LLC20180—
+4K173791Leksell GammaPlanElekta Instrument AB201832
+4K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+4K151435MRCATPhilips Medical Systems MR Finland20164—
+4K141860RaystationRaysearch Laboratories AB2014175
+4K132971MonacoImpac Medical Systems, Inc.201374
+5K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+5K231825Panther TPSProwess, Inc.20230—
+5K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D…Adaptiiv20223—
+5K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+5K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+5K151233MonacoImpac Medical Systems, Inc.201569
+6K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc.20241—
+6K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc.20240—
+6K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+7K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.20260—
+7K211841MRI PlannerSpectronic Medical AB20220—
+7K214081MRCAT Head & NeckPhilips OY20220—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+7K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+10K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+11K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+12K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+13K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+14K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+15K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+16K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—