510(k) Report

Devices descending from K140528

31 later devices reach True Beam, True Beam STX, Edge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+1K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+2K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+2K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+2K160440Leksell Gamma Knife IconElekta Instrument AB201631
+2K150706VitalBeamVarian Medical Systems, Inc.201501
+3K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+3K172013VitalBeamVarian Medical Systems, Inc.20175—
+3K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+3K170817HalcyonVarian Medical Systems, Inc.201715—
+4K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+4K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+4K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+4K181032HalcyonVarian Medical Systems, Inc.201814—
+5K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+5K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+5K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+5K193207TaiChiAOur United Corporation20201—
+5K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+6K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+6K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+6K210921TaiChiBOur United Corporation20210—
+6K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+7K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—
+7K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+7K232479ART-PlanTherapanacea20232—
+7K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20260—