510(k) Report

Devices descending from K911904

231 later devices reach Models Ues-10 & PSD-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+8K240504PLASMA EDGE SystemLamidey Noury Medical20240—
+8K230985Planmeca VisoPlanmeca Oy20233—
+8K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.20230—
+8K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+8K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+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
+8K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+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—
+9K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+9K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+9K243884TavipilotCaranx Medical20250—
+9K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+9K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+9K233230See Factor CT3™Epica International, Inc.20240—
+9K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+9K223550DMXDel Medical, Inc.20230—
+9K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+9K213479D²RS and D²RS 9090Stephanix20211—
+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—
+9K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+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—
+9K133434Genesis IIDornier Medtech America, Inc.20142—
+9K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+10K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+10K252503Intelligent NRCanon, Inc.20260—
+10K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+10K2434463DXRGE Medical Systems SCS20250—
+10K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+10K233543YSIO X.preeSiemens Medical Solutions20241—
+10K231995AcuityUDRRadmedix, LLC20230—
+10K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+10K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+10K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+10K221335D²RS and D²RS 9090Stephanix20220—
+10K220871NautilusDornier Medtech America, Inc.20220—
+10K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+10K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+10K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+10K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+10K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+10K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+10K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+10K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+10K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+10K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I