510(k) Report

Devices descending from K943304

210 later devices reach 3D Surgical Endoscopy System for Urology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+8K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+8K233230See Factor CT3™Epica International, Inc.20240—
+8K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+8K223550DMXDel Medical, Inc.20230—
+8K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+8K213479D²RS and D²RS 9090Stephanix20211—
+8K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+8K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+8K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+8K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+8K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+8K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+8K200887AS-10Canon, Inc.20200—
+8K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+8K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+8K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+8K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+8K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+8K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+8K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+8K180651Uroview FD IIPausch Medical GmbH20180—
+8K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+8K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+8K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+8K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+8K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+8K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+8K151904SyncVision SystemVolcano Corporation201521
+8K151485GenesisDornier Medtech America, Inc.20151—
+8K133434Genesis IIDornier Medtech America, Inc.20142—
+8K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K252503Intelligent NRCanon, Inc.20260—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+9K2434463DXRGE Medical Systems SCS20250—
+9K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+9K233543YSIO X.preeSiemens Medical Solutions20241—
+9K231995AcuityUDRRadmedix, LLC20230—
+9K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+9K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+9K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+9K221335D²RS and D²RS 9090Stephanix20220—
+9K220871NautilusDornier Medtech America, Inc.20220—
+9K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+9K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+9K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+9K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+9K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+9K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+9K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+9K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+9K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+9K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+9K161756SyncVision SystemVolcano Corporation201611
+10K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+10K251199Allia MoveoGE Medical Systems SCS202501
+10K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+10K250738YSIO X.preeSiemens Medical Solutions20250—
+10K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+10K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+10K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+10K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+10K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+10K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+10K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+10K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+10K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+10K172574SyncVision SystemVolcano Corporation201701
+11K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+11K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+11K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+11K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I