510(k) Report

Devices descending from K981993

175 later devices reach Olympus Integrated Endosurgery System Endoalpha through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+1K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20053—
+1K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+1K022270Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd.20028—
+1K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp.2000157—
+2K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+2K070556Brainsuite NetBrainlab AG20072—
+2K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20061—
+2K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+2K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052—
+2K041494Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2)…Olympus Corporation20046—
+2K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030—
+3K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+3K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+3K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+3K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+3K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation20055—
+4K191678IP ConverterSony Electronics, Inc.20200—
+4K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+4K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+4K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications20102—
+4K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation20101—
+4K091166IMRXImris, Inc.20091—
+4K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+4K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+4K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+4K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+5K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+5K223060DigiX FDXAllengers Medical Systems Limited20224—
+5K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+5K192541DigiX FDXAllengers Medical Systems Limited20195—
+5K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+5K162529DigiX FDXAllengers Medical Systems Limited20176—
+5K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+5K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+5K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+5K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+5K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+5K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+5K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+5K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+5K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+5K121513Multix FusionSiemens Medical Solution2012324
+5K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+5K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+5K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+5K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+5K102763Systems IntegrationOlympus Medical Systems Corporation20110—
+5K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+5K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+5K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+5K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+5K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+5K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+6K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+6K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+6K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+6K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+6K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+6K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+6K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+6K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+6K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+6K161019Uroview FDPausch Medical GmbH201621
+6K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+6K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+6K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+6K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+6K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+6K150663Diagnostic X-ray SystemOsko, Inc.20150—
+6K143281Ultimax-iToshibamedical Systems Corporation20150—
+6K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+6K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+6K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+6K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+6K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+6K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+6K133278Discovery Igs 740GE Medical Systems SCS201445
+6K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+6K132558Sync-RX SystemVolcano Corporation201331
+6K122768GenesisDornier Medtech America, Inc.20134—
+6K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+6K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+6K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+6K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+6K101042BladeviewAccogent, LLC20100—
+6K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+7K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K243884TavipilotCaranx Medical20250—
+7K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+7K233230See Factor CT3™Epica International, Inc.20240—
+7K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+7K223550DMXDel Medical, Inc.20230—
+7K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+7K213479D²RS and D²RS 9090Stephanix20211—