510(k) Report

Devices descending from K962699

848 later devices reach Radworks Medical Imaging Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K243350Rapid Neuro3DIschemaview, Inc.20251—
+13K241211CoLumboSmart Soft Healthcare20242—
+13K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K220497CoLumboSmart Soft Healthcare AD20226—
+13K213787Monaco RTP SystemElekta Solutions AB20222—
+13K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+13K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+13K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+13K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+14K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+14K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+14K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—
+14K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+14K250367CoLumboXSmart Soft Healthcare AD20250—
+14K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+14K240793MSKaiMskai20240—
+14K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+14K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+14K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+14K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+14K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+14K223233Monaco RTP SystemElekta Solutions AB20231—
+14K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+15K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+15K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+15K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+15K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+15K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+15K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+16K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+16K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+16K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+16K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+16K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+17K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+17K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+18K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+19K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—