510(k) Report

Devices descending from K010721

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040675Axiom Artis USiemens Medical Systems, Inc.2004491
+1K021021Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc.200221821
+2K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+2K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+2K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+2K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+2K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+2K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc.20079—
+2K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc.200610—
+2K051133Arcadis AvanticSiemens Medical Solutions USA, Inc.200520—
+2K033244Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionGe Medical Systems, Inc.2003758
+3K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+3K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+3K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+3K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+3K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+3K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+3K132094Cios AlphaSiemens Medi Cal Solutions, Inc.2014198
+3K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+3K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+3K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+3K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+3K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+3K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+3K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+3K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+3K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+3K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+3K091166IMRXImris, Inc.20091—
+3K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+3K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+3K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+3K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+3K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+3K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+3K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+4K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+4K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+4K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+4K223060DigiX FDXAllengers Medical Systems Limited20224—
+4K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+4K214097Explorer Air IISurgvision GmbH20222—
+4K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+4K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+4K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+4K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+4K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+4K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+4K192761Asimov-MKS Imaging SystemOnlume, Inc.20200—
+4K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+4K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+4K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+4K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+4K161019Uroview FDPausch Medical GmbH201621
+4K153244Cios FusionSiemens Medical Solutions USA, Inc.2016151
+4K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+4K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+4K153147Cios ConnectSiemens Medical Solutions USA, Inc.20160—
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+4K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+4K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+4K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+4K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+4K122768GenesisDornier Medtech America, Inc.20134—
+4K121513Multix FusionSiemens Medical Solution2012324
+4K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+4K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+4K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+4K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+4K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+4K111209Integrated Innova - S5I System OptionGE Healthcare201182
+4K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+4K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+4K101042BladeviewAccogent, LLC20100—
+4K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+4K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+4K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+4K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+4K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+4K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+4K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+5K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+5K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+5K243884TavipilotCaranx Medical20250—
+5K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+5K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+5K222240Explorer Air® IISurgvision GmbH20231—
+5K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+5K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+5K213479D²RS and D²RS 9090Stephanix20211—
+5K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+5K212336Soteria.AIOmega Medical Imaging, LLC20211—
+5K203010Platinum dRF Imaging SystemApelem-Dms Group20210—