510(k) Report

Devices descending from K993037

330 later devices reach LCV+ Version 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+7K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+7K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+7K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+7K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+7K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+7K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+7K172418OpenSightNovarad Corporation20185—
+7K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+7K161756SyncVision SystemVolcano Corporation201611
+7K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+7K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+7K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+7K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+7K110256The IC-Pro SystemPaieon, Inc.201115—
+7K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+7K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+8K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+8K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+8K250738YSIO X.preeSiemens Medical Solutions20250—
+8K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+8K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+8K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+8K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+8K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+8K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+8K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K220146VisARNovarad Corporation20220—
+8K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+8K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+8K172574SyncVision SystemVolcano Corporation201701
+8K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+8K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+8K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+8K133993Caas WorkstationPie Medical Imaging201410—
+8K120282CardnavPaieon, Inc.20120—
+8K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+8K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+8K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+8K113594C-THV SystemPaieon, Inc.20120—
+8K113076Caas a-ValvePie Medical Imaging BV20121—
+9K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+9K251827Azurion R3.1Philips Medical Systems B.V.20251—
+9K243069Lumys (V1)Intradys20250—
+9K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+9K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K232189OrionXRHoth Intelligence, Inc.20230—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+9K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+9K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+9K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+9K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+9K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+9K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+9K151780CAAS WorkstationPie Medical Imaging BV20169—
+9K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+9K143044CAAS A-ValvePie Medical Imaging BV20150—
+9K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+9K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+10K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+10K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+10K254186Azurion R3.1Philips Medical Systems B.V.20260—
+10K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+10K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+10K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+10K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+10K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+10K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+10K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+10K180019CAAS WorkstationPie Medical Imaging BV20188—
+10K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+11K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+11K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+11K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+11K251355X1-FFRSpectrawave, Inc.20250—
+11K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+11K232147CAAS WorkstationPie Medical Imaging BV20241—
+11K233532MULTIX Impact ESiemens Medical Solutions20230—
+11K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+11K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+11K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+11K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+11K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+12K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+12K243769QFR (3.0)Qfr Solutions BV20250—
+12K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+12K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+12K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212