510(k) Report

Devices descending from K001163

69 later devices reach DMLC IV-Ergo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111676APEXElekta Limited201101
+1K080601Ergo++ Version 1.73D Line Medical Systems S.R.L.2008292
+1K040474AccusoftDirex Systems Corp.20042—
+1K032762Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc.200352—
+1K013535Evtool Model # V. 1.03D Line USA, Inc.200230—
+2K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+2K132971MonacoImpac Medical Systems, Inc.201374
+2K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+2K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+2K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+2K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090—
+2K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc.200901
+2K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+2K062032Accusoft, Accusoft XLDirex Systems Corp.20061—
+2K061440P.D.Decimal, Inc.20068—
+3K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+3K151233MonacoImpac Medical Systems, Inc.201569
+3K103093Leksell GammaplanElekta Instrument AB201051
+3K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+3K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+3K083672P.D Software.Decimal, Inc.20097—
+3K063482Crossplan / Accusoft-XL V.4.04Direx Systems Corp.20060—
+4K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+4K193459Panther StereotacticProwess, Inc.20201—
+4K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+4K183037Monaco RTP SystemElekta, Inc.201856
+4K151666Leksell GammaPlanElekta Instrument AB201541
+4K151369.decimal p.d.Decimal, LLC20156—
+4K140187Ray StationRaysearch Laboratories AB2014191
+4K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+5K231825Panther TPSProwess, Inc.20230—
+5K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+5K211760Panther OISProwess, Inc.20210—
+5K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+5K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+5K192554decimal3D.Decimal, LLC20190—
+5K190178Monaco RTP SystemElekta, Inc.201945
+5K1802893D Bolus Software3D Bolus, Inc.20184—
+5K173940Astroid Planning App.Decimal, LLC20180—
+5K173791Leksell GammaPlanElekta Instrument AB201832
+5K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+5K151435MRCATPhilips Medical Systems MR Finland20164—
+5K141860RaystationRaysearch Laboratories AB2014175
+6K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+6K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+6K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D…Adaptiiv20223—
+6K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+6K202789Monaco Rtp SystemElekta Solutions AB20213—
+6K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+6K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+7K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc.20241—
+7K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc.20240—
+7K213787Monaco RTP SystemElekta Solutions AB20222—
+7K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+7K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+7K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+8K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.20260—
+8K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+8K223233Monaco RTP SystemElekta Solutions AB20231—
+8K211841MRI PlannerSpectronic Medical AB20220—
+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
+9K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+9K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+9K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+10K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+10K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+11K200569RayStationRaySearch Laboratories AB (PUBL)2020614