510(k) Report

Devices descending from K013112

47 later devices reach Focal Sim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+1K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc.200232—
+2K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+2K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc.2006191
+2K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc.20031617
+3K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+3K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+3K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+3K060633Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0Siemens Medical Solutions USA, Inc.200651
+3K060226Oncor ExpressionSiemens Medical Solutions USA, Inc.20061372
+3K052315Simtec IM-Maxx 2 OptionSiemens Medical Solutions USA, Inc.20054—
+4K193459Panther StereotacticProwess, Inc.20201—
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K132971MonacoImpac Medical Systems, Inc.201374
+4K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+4K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+4K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+4K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+4K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+4K083502Panther Realart, Model 4.7Prowess, Inc.20090—
+4K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+4K072485Artiste MV SASiemens Medical Solutions USA, Inc.20071124
+5K231825Panther TPSProwess, Inc.20230—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+5K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+5K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+6K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K190178Monaco RTP SystemElekta, Inc.201945
+8K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+10K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+11K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+11K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—