510(k) Report

Devices descending from K896095

850 later devices reach Images-on-Call Teleradiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+14K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+14K243350Rapid Neuro3DIschemaview, Inc.20251—
+14K241211CoLumboSmart Soft Healthcare20242—
+14K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+14K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+14K220497CoLumboSmart Soft Healthcare AD20226—
+14K213787Monaco RTP SystemElekta Solutions AB20222—
+14K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+14K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+14K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+14K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+15K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+15K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+15K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—
+15K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+15K250367CoLumboXSmart Soft Healthcare AD20250—
+15K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+15K240793MSKaiMskai20240—
+15K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+15K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+15K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+15K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+15K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+15K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+15K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+15K223233Monaco RTP SystemElekta Solutions AB20231—
+15K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+16K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+16K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+16K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+16K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+16K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+16K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+16K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+16K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+16K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+16K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+16K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+16K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+17K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+17K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+17K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+17K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+17K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+17K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+18K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+18K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+19K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+20K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—