510(k) Report

Devices descending from K082122

38 later devices reach MLCI2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121328AgilityElekta, Ltd.2012373
+2K123808AgilityElekta, Ltd.2013362
+3K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+3K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.2014312
+4K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+4K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+4K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+5K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+5K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+5K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+5K160440Leksell Gamma Knife IconElekta Instrument AB201631
+5K150706VitalBeamVarian Medical Systems, Inc.201501
+6K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+6K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+6K172013VitalBeamVarian Medical Systems, Inc.20175—
+6K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+6K170817HalcyonVarian Medical Systems, Inc.201715—
+7K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+7K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+7K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+7K181032HalcyonVarian Medical Systems, Inc.201814—
+8K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+8K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+8K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+8K193207TaiChiAOur United Corporation20201—
+8K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+9K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+9K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+9K210921TaiChiBOur United Corporation20210—
+9K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+10K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—
+10K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+10K232479ART-PlanTherapanacea20232—
+10K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+11K253078ART.1-USSeetreat Pty, Ltd.20260—
+11K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—
+11K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+12K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20260—