510(k) Report

Devices descending from K003266

440 later devices reach Siremobil Iso-C 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+11K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+12K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+12K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+12K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+12K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+12K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+13K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—
+13K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+13K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+13K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+13K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+13K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+13K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+14K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+14K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+14K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+14K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+14K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+14K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+15K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+15K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+15K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+16K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+16K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+17K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+18K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—