510(k) Report

Devices descending from K080886

33 later devices reach Iplan RT Image through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103246Iplan RTBrainlab AG2011322
+2K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+2K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+2K120387RaystationRaysearch Laboratories AB2012226
+3K223279RT Elements (4.0)Brainlab AG20231—
+3K202284OncospaceOncospace, Inc.20214—
+3K130617RaystationRaysearch Laboratories AB2013216
+4K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+4K222803OncospaceOncospace, Inc.20233—
+4K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+4K140187Ray StationRaysearch Laboratories AB2014191
+5K253050RadOncAIInformai20260—
+5K250064Dose+ (1.0)Mvision AI OY20250—
+5K242748OncospaceOncospace, Inc.20250—
+5K173940Astroid Planning App.Decimal, LLC20180—
+5K141860RaystationRaysearch Laboratories AB2014175
+6K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+7K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+8K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+8K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+9K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+10K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+12K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+13K223233Monaco RTP SystemElekta Solutions AB20231—
+13K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+14K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+14K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+15K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+16K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+17K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—