510(k) Report

Devices descending from K926258

382 later devices reach DLX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+7K233230See Factor CT3™Epica International, Inc.20240—
+7K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+7K223550DMXDel Medical, Inc.20230—
+7K220039AutoSegAi Medic, Inc.20221—
+7K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+7K220727inHEART MODELSInheart, Sas20221—
+7K220871NautilusDornier Medtech America, Inc.20220—
+7K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+7K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+7K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+7K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+7K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+7K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+7K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+7K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+7K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+7K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+7K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+7K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+7K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+7K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+7K163622Lung VisionBodyvision Medical, Ltd.20176—
+7K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+7K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+7K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+7K160937SenolrisGE Healthcare20160—
+7K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+7K151904SyncVision SystemVolcano Corporation201521
+7K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+7K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+7K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+7K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+7K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+8K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+8K251199Allia MoveoGE Medical Systems SCS202501
+8K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+8K233543YSIO X.preeSiemens Medical Solutions20241—
+8K231683inHEART ModelsInheart, Sas20240—
+8K231995AcuityUDRRadmedix, LLC20230—
+8K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+8K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+8K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+8K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+8K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+8K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+8K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+8K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+8K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+8K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+8K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+8K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+8K172418OpenSightNovarad Corporation20185—
+8K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+8K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+8K161756SyncVision SystemVolcano Corporation201611
+8K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+8K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+8K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+8K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+8K110256The IC-Pro SystemPaieon, Inc.201115—
+8K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+8K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+9K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+9K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+9K250738YSIO X.preeSiemens Medical Solutions20250—
+9K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+9K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+9K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+9K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K221796Cyware 4H and Cysart 4HAbys Medical20221—
+9K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+9K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+9K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+9K220146VisARNovarad Corporation20220—
+9K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+9K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+9K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+9K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K172574SyncVision SystemVolcano Corporation201701
+9K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+9K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+9K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+9K133993Caas WorkstationPie Medical Imaging201410—
+9K120282CardnavPaieon, Inc.20120—
+9K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+9K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+9K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+9K113594C-THV SystemPaieon, Inc.20120—
+9K113076Caas a-ValvePie Medical Imaging BV20121—
+10K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—