510(k) Report

Devices descending from K021021

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+1K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+1K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+1K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+1K033244Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionGe Medical Systems, Inc.2003758
+2K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+2K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+2K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+2K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+2K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+2K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+2K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+2K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+2K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+2K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+2K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+2K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+2K091166IMRXImris, Inc.20091—
+2K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+2K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+2K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+2K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+2K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC20062238
+2K060259Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC2006474
+2K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare20057450
+3K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+3K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+3K223060DigiX FDXAllengers Medical Systems Limited20224—
+3K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+3K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+3K192541DigiX FDXAllengers Medical Systems Limited20195—
+3K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+3K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+3K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+3K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+3K162529DigiX FDXAllengers Medical Systems Limited20176—
+3K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+3K161019Uroview FDPausch Medical GmbH201621
+3K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+3K152352Stereo 3D option for Vision ApplicationsGE Medical Systems SCS20161—
+3K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+3K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+3K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+3K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+3K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+3K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+3K122768GenesisDornier Medtech America, Inc.20134—
+3K121513Multix FusionSiemens Medical Solution2012324
+3K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+3K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+3K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+3K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+3K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+3K111209Integrated Innova - S5I System OptionGE Healthcare201182
+3K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+3K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+3K101042BladeviewAccogent, LLC20100—
+3K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+3K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C201021—
+3K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+3K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare2009111
+3K081624Infx-8000F (Infinix Csi and Infinix Dpi)Toshiba America Medical Systems, In.C2008138
+3K081621Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C2008101
+3K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C2008231
+4K243884TavipilotCaranx Medical20250—
+4K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+4K230985Planmeca VisoPlanmeca Oy20233—
+4K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS20220—
+4K213479D²RS and D²RS 9090Stephanix20211—
+4K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+4K212336Soteria.AIOmega Medical Imaging, LLC20211—
+4K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+4K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+4K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+4K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+4K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+4K200887AS-10Canon, Inc.20200—
+4K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+4K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+4K182415Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation201805
+4K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+4K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+4K180651Uroview FD IIPausch Medical GmbH20180—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+4K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+4K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+4K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+4K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+4K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+4K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+4K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+4K151485GenesisDornier Medtech America, Inc.20151—
+4K150663Diagnostic X-ray SystemOsko, Inc.20150—
+4K143281Ultimax-iToshibamedical Systems Corporation20150—
+4K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+4K133434Genesis IIDornier Medtech America, Inc.20142—
+4K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+4K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+4K133278Discovery Igs 740GE Medical Systems SCS201445