510(k) Report

Devices descending from K994231

157 later devices reach Siemens Integrated Operating System (Sios) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+1K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+2K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+2K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+2K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+3K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+3K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+3K091166IMRXImris, Inc.20091—
+3K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+3K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+3K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+3K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+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—
+4K192541DigiX FDXAllengers Medical Systems Limited20195—
+4K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+4K162529DigiX FDXAllengers Medical Systems Limited20176—
+4K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+4K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+4K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+4K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+4K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+4K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+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
+4K121513Multix FusionSiemens Medical Solution2012324
+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
+4K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+4K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+4K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+4K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+4K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+4K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+4K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+5K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+5K230985Planmeca VisoPlanmeca Oy20233—
+5K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+5K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+5K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+5K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+5K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+5K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+5K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+5K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+5K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+5K161019Uroview FDPausch Medical GmbH201621
+5K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+5K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+5K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+5K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+5K150663Diagnostic X-ray SystemOsko, Inc.20150—
+5K143281Ultimax-iToshibamedical Systems Corporation20150—
+5K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+5K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+5K133278Discovery Igs 740GE Medical Systems SCS201445
+5K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+5K132558Sync-RX SystemVolcano Corporation201331
+5K122768GenesisDornier Medtech America, Inc.20134—
+5K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+5K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+5K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+5K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+5K101042BladeviewAccogent, LLC20100—
+5K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+6K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+6K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+6K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+6K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+6K243884TavipilotCaranx Medical20250—
+6K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+6K233230See Factor CT3™Epica International, Inc.20240—
+6K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+6K223550DMXDel Medical, Inc.20230—
+6K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+6K213479D²RS and D²RS 9090Stephanix20211—
+6K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+6K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+6K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+6K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+6K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+6K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+6K200887AS-10Canon, Inc.20200—
+6K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+6K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+6K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+6K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+6K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+6K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+6K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+6K180651Uroview FD IIPausch Medical GmbH20180—
+6K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+6K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+6K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—