510(k) Report

Devices descending from K021021

218 later devices reach Modular Angiography System Axiom Artis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+4K132558Sync-RX SystemVolcano Corporation201331
+4K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+4K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+4K120073Infx-8000V withToshibamedical Systems Corporation2012203
+4K113052Infinix-CciToshiba America Medical Systems, In.C201171
+4K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+4K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+5K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+5K252503Intelligent NRCanon, Inc.20260—
+5K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+5K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+5K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+5K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+5K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+5K233230See Factor CT3™Epica International, Inc.20240—
+5K223550DMXDel Medical, Inc.20230—
+5K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+5K221335D²RS and D²RS 9090Stephanix20220—
+5K220871NautilusDornier Medtech America, Inc.20220—
+5K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+5K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+5K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+5K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+5K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+5K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+5K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+5K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+5K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+5K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+5K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+5K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+5K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+5K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+5K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+5K151904SyncVision SystemVolcano Corporation201521
+5K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+5K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+5K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+5K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+6K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+6K2434463DXRGE Medical Systems SCS20250—
+6K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+6K233543YSIO X.preeSiemens Medical Solutions20241—
+6K231995AcuityUDRRadmedix, LLC20230—
+6K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+6K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+6K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+6K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+6K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+6K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+6K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+6K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+6K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+6K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+6K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+6K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+6K181804Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation201823
+6K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+6K161756SyncVision SystemVolcano Corporation201611
+6K143225INFX-8000V with Wireless FootswitchToshibamedical Systems Corporation201592
+6K141541Xidf-AWS801, Angio Workstation, V5.31Toshibamedical Systems Corporation20147—
+7K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+7K251199Allia MoveoGE Medical Systems SCS202501
+7K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+7K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+7K250738YSIO X.preeSiemens Medical Solutions20250—
+7K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+7K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+7K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+7K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+7K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+7K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+7K210900Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation202117
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+7K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+7K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+7K172574SyncVision SystemVolcano Corporation201701
+7K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+7K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+8K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+8K251827Azurion R3.1Philips Medical Systems B.V.20251—
+8K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+8K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+8K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+8K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+9K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+9K254186Azurion R3.1Philips Medical Systems B.V.20260—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+9K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—