510(k) Report

Devices descending from K052220

34 later devices reach Iplan RT Fibertracking through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080886Iplan RT ImageBrainlab AG200833—
+2K103246Iplan RTBrainlab AG2011322
+3K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+3K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+3K120387RaystationRaysearch Laboratories AB2012226
+4K223279RT Elements (4.0)Brainlab AG20231—
+4K202284OncospaceOncospace, Inc.20214—
+4K130617RaystationRaysearch Laboratories AB2013216
+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—