510(k) Report

Devices descending from K982821

165 later devices reach MMS Therpacplus B3DTUI Model Number 6.7 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+6K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+6K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+6K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+6K083502Panther Realart, Model 4.7Prowess, Inc.20090—
+6K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+6K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated2008137
+6K072485Artiste MV SASiemens Medical Solutions USA, Inc.20071124
+7K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+7K253835AffinityHermes Medical Solutions AB20260—
+7K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+7K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+7K242925MR Contour DLGE Healthcare20250—
+7K231825Panther TPSProwess, Inc.20230—
+7K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+7K220813Art-PlanTherapanacea20224—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+7K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+7K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated201111—
+7K112446Tomotherapy Treatment SystemTomotherapy Incorporated20110—
+7K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+8K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+8K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+8K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K230023ART-PlanTherapanacea Sas20233—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+8K121934Tomotherapy Treatment SystemAccuray Incorporated2012108
+9K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K232479ART-PlanTherapanacea20232—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K190978RefleXion Medical Radiotherapy SystemReflexion Medical, Inc.202001
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K171837TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated201701
+9K161136Precision Treatment Planning SystemAccuray Incorporated20162—
+9K161146Radixact Treatment Delivery SystemAccuray Incorporated201631
+9K152488Onrad Treatment SystemAccuray Incorporated20150—
+10K261306AI Contouring (VA10A)Varian Medical Systems20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+10K253270Contour ProtégéAI+Mim Software, Inc.20260—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated20201—
+10K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated20180—
+10K171086Accuray Precision Treatment Planning SystemAccuray Incorporated20171—
+11K223159Radixact Treatment Delivery SystemAccuray Incorporated20230—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+11K212794Accuray Precision Treatment Planning SystemAccuray Incorporated20210—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K223233Monaco RTP SystemElekta Solutions AB20231—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—