510(k) Report

Devices descending from K041703

56 later devices reach IPLAN! through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053127IPLANBrainlab AG200654—
+1K052220Iplan RT FibertrackingBrainlab AG200534—
+2K101627IPLANBrainlab AG201112—
+2K093117Digital LightboxBrainlab AG200952
+2K080886Iplan RT ImageBrainlab AG200833—
+2K080608Digital LightboxBrainlab AG20086—
+3K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationBrainlab AG20211—
+3K163666neuro inspireRensihaw Plc20170—
+3K153653DICOM ViewerBrainlab AG20164—
+3K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+3K103246Iplan RTBrainlab AG2011322
+4K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+4K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+4K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+4K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+4K191014Elements ViewerBrainlab AG20203—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+4K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+4K120387RaystationRaysearch Laboratories AB2012226
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+5K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+5K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+5K223279RT Elements (4.0)Brainlab AG20231—
+5K202284OncospaceOncospace, Inc.20214—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+5K130617RaystationRaysearch Laboratories AB2013216
+6K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—
+6K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+6K222803OncospaceOncospace, Inc.20233—
+6K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+6K140187Ray StationRaysearch Laboratories AB2014191
+7K253050RadOncAIInformai20260—
+7K250064Dose+ (1.0)Mvision AI OY20250—
+7K242748OncospaceOncospace, Inc.20250—
+7K173940Astroid Planning App.Decimal, LLC20180—
+7K141860RaystationRaysearch Laboratories AB2014175
+8K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+9K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+10K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+10K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+11K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+12K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+13K202789Monaco Rtp SystemElekta Solutions AB20213—
+13K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+14K213787Monaco RTP SystemElekta Solutions AB20222—
+14K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+15K223233Monaco RTP SystemElekta Solutions AB20231—
+15K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+16K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+16K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+17K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+18K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+19K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—