510(k) Report

Devices descending from K020546

442 later devices reach Fusion 7D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K261210Cleerly PlaqueCleerly, Inc.20260—
+10K260588Cleerly LABSCleerly, Inc.20260—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+10K250367CoLumboXSmart Soft Healthcare AD20250—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240793MSKaiMskai20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K220039AutoSegAi Medic, Inc.20221—
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K220727inHEART MODELSInheart, Sas20221—
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K253270Contour ProtégéAI+Mim Software, Inc.20260—
+11K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K231683inHEART ModelsInheart, Sas20240—
+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—
+12K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+12K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+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—