510(k) Report

Devices descending from K060816

350 later devices reach Mim 4.0 (Neuro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K261306AI Contouring (VA10A)Varian Medical Systems20260—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+10K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K240793MSKaiMskai20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+11K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+12K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+12K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+12K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+13K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+13K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+13K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+13K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+14K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+14K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+15K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+16K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—