510(k) Report

Devices descending from K950103

357 later devices reach Laparoscope, Hand Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+7K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+7K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+7K121513Multix FusionSiemens Medical Solution2012324
+7K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+7K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+7K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+7K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+7K102763Systems IntegrationOlympus Medical Systems Corporation20110—
+7K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+7K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+7K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+7K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+7K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+7K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+8K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+8K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+8K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+8K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+8K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+8K230985Planmeca VisoPlanmeca Oy20233—
+8K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+8K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+8K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+8K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+8K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+8K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+8K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+8K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+8K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+8K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+8K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+8K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+8K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+8K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+8K161019Uroview FDPausch Medical GmbH201621
+8K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+8K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+8K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+8K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+8K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+8K150663Diagnostic X-ray SystemOsko, Inc.20150—
+8K143281Ultimax-iToshibamedical Systems Corporation20150—
+8K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+8K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+8K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+8K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+8K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+8K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+8K133278Discovery Igs 740GE Medical Systems SCS201445
+8K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+8K132558Sync-RX SystemVolcano Corporation201331
+8K122768GenesisDornier Medtech America, Inc.20134—
+8K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+8K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+8K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+8K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+8K101042BladeviewAccogent, LLC20100—
+8K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+9K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+9K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+9K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+9K243884TavipilotCaranx Medical20250—
+9K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+9K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+9K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+9K233230See Factor CT3™Epica International, Inc.20240—
+9K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+9K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+9K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+9K223550DMXDel Medical, Inc.20230—
+9K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+9K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+9K213479D²RS and D²RS 9090Stephanix20211—
+9K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+9K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+9K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+9K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+9K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+9K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+9K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+9K200887AS-10Canon, Inc.20200—
+9K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+9K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+9K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+9K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+9K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+9K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+9K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+9K180651Uroview FD IIPausch Medical GmbH20180—
+9K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+9K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+9K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+9K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+9K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+9K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+9K151904SyncVision SystemVolcano Corporation201521
+9K151485GenesisDornier Medtech America, Inc.20151—