510(k) Report

Devices descending from K001643

183 later devices reach Varis 1.4G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212116VBrain-OARVysioneer, Inc.20211—
+7K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+7K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K202700ART-PlanTherapanacea20215—
+7K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+7K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+7K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+7K182076Elekta UnityElekta Limited201834
+7K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+7K161400ImagingRing SystemMedphoton GmbH20161—
+7K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+7K151561Leksell Gamma Knife IconElekta Instrument AB201541
+7K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+8K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+8K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.20260—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+8K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—
+8K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+8K243301MapRTVision Rt, Ltd.20250—
+8K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+8K242925MR Contour DLGE Healthcare20250—
+8K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+8K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+8K232514MIM – Dose AnalysisMim Software, Inc.20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+8K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+8K220813Art-PlanTherapanacea20224—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+8K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+8K192482Elekta UnityElekta Limited201923
+8K191267ImagingRing System on RailsMedphoton GmbH20190—
+8K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+8K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+8K160440Leksell Gamma Knife IconElekta Instrument AB201631
+8K150706VitalBeamVarian Medical Systems, Inc.201501
+9K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20260—
+9K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+9K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+9K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+9K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+9K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+9K230023ART-PlanTherapanacea Sas20233—
+9K223233Monaco RTP SystemElekta Solutions AB20231—
+9K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+9K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K212114Elekta UnityElekta Solutions AB202111
+9K172013VitalBeamVarian Medical Systems, Inc.20175—
+9K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+9K170817HalcyonVarian Medical Systems, Inc.201715—
+10K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+10K251883MIM – LesionID ProMim Software, Inc.20250—
+10K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+10K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+10K223209Elekta UnityElekta Solutions AB20230—
+10K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+10K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+10K181032HalcyonVarian Medical Systems, Inc.201814—
+11K261306AI Contouring (VA10A)Varian Medical Systems20260—
+11K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+11K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+11K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+11K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+11K193207TaiChiAOur United Corporation20201—
+12K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+12K210921TaiChiBOur United Corporation20210—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—