510(k) Report

Devices descending from K963184

178 later devices reach Olympus Subcutaneous Endoscopy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012724Smith & Nephew Vascular Videoendoscope System, Model 7209273Smith & Nephew, Inc.20010—
+1K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co.1998175—
+1K973232Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated…Olympus Winter & Ibe GmbH19970—
+2K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+2K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20053—
+2K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+2K022270Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd.20028—
+2K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp.2000157—
+3K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+3K070556Brainsuite NetBrainlab AG20072—
+3K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20061—
+3K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+3K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052—
+3K041494Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2)…Olympus Corporation20046—
+3K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030—
+4K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+4K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+4K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+4K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+4K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation20055—
+5K191678IP ConverterSony Electronics, Inc.20200—
+5K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+5K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+5K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications20102—
+5K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation20101—
+5K091166IMRXImris, Inc.20091—
+5K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+5K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+5K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+5K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+6K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+6K223060DigiX FDXAllengers Medical Systems Limited20224—
+6K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+6K192541DigiX FDXAllengers Medical Systems Limited20195—
+6K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+6K162529DigiX FDXAllengers Medical Systems Limited20176—
+6K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+6K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+6K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+6K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+6K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+6K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+6K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+6K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+6K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+6K121513Multix FusionSiemens Medical Solution2012324
+6K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+6K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+6K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+6K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+6K102763Systems IntegrationOlympus Medical Systems Corporation20110—
+6K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+6K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+6K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+6K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+6K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+6K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+7K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+7K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+7K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+7K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+7K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+7K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+7K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+7K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+7K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+7K161019Uroview FDPausch Medical GmbH201621
+7K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+7K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+7K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+7K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+7K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+7K150663Diagnostic X-ray SystemOsko, Inc.20150—
+7K143281Ultimax-iToshibamedical Systems Corporation20150—
+7K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+7K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+7K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+7K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+7K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+7K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+7K133278Discovery Igs 740GE Medical Systems SCS201445
+7K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+7K132558Sync-RX SystemVolcano Corporation201331
+7K122768GenesisDornier Medtech America, Inc.20134—
+7K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+7K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+7K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+7K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+7K101042BladeviewAccogent, LLC20100—
+7K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+8K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+8K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+8K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+8K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+8K243884TavipilotCaranx Medical20250—
+8K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+8K233230See Factor CT3™Epica International, Inc.20240—
+8K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—