510(k) Report

Devices descending from K950945

215 later devices reach Cooper Laser Sonics Cusa Model 200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+9K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+9K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+9K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+9K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+9K161019Uroview FDPausch Medical GmbH201621
+9K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+9K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+9K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+9K151737MedicVOD SystemOrpheus Medical, Ltd.20160—
+9K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+9K150663Diagnostic X-ray SystemOsko, Inc.20150—
+9K143281Ultimax-iToshibamedical Systems Corporation20150—
+9K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+9K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+9K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+9K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+9K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+9K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+9K133278Discovery Igs 740GE Medical Systems SCS201445
+9K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+9K132558Sync-RX SystemVolcano Corporation201331
+9K122768GenesisDornier Medtech America, Inc.20134—
+9K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+9K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+9K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+9K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+9K101042BladeviewAccogent, LLC20100—
+9K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems201031
+10K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+10K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+10K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+10K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+10K243884TavipilotCaranx Medical20250—
+10K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+10K233230See Factor CT3™Epica International, Inc.20240—
+10K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlCanon, Inc.20241—
+10K223550DMXDel Medical, Inc.20230—
+10K221516ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.202233
+10K213479D²RS and D²RS 9090Stephanix20211—
+10K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+10K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+10K201670YSIO X.preeSiemens Medical Solutions USA, Inc.202022
+10K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+10K201156ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.202056
+10K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+10K200887AS-10Canon, Inc.20200—
+10K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+10K190768ARTIS iconoSiemens Medical Solutions USA, Inc.2019104
+10K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited20190—
+10K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+10K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+10K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+10K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.201823
+10K180651Uroview FD IIPausch Medical GmbH20180—
+10K173823Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography…Summit Industries, LLC20180—
+10K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+10K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+10K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+10K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+10K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+10K151904SyncVision SystemVolcano Corporation201521
+10K151485GenesisDornier Medtech America, Inc.20151—
+10K133434Genesis IIDornier Medtech America, Inc.20142—
+10K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+11K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+11K252503Intelligent NRCanon, Inc.20260—
+11K2434463DXRGE Medical Systems SCS20250—
+11K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+11K233543YSIO X.preeSiemens Medical Solutions20241—
+11K231995AcuityUDRRadmedix, LLC20230—
+11K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+11K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+11K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+11K221335D²RS and D²RS 9090Stephanix20220—
+11K220871NautilusDornier Medtech America, Inc.20220—
+11K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+11K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+11K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+11K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+11K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+11K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+11K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+11K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+11K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+11K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+11K161756SyncVision SystemVolcano Corporation201611
+12K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+12K251199Allia MoveoGE Medical Systems SCS202501
+12K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+12K250738YSIO X.preeSiemens Medical Solutions20250—
+12K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+12K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+12K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+12K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+12K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+12K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+12K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+12K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+12K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I