510(k) Report

Devices descending from K053127

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

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