510(k) Report

Devices descending from K926258

382 later devices reach DLX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+5K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+5K162529DigiX FDXAllengers Medical Systems Limited20176—
+5K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+5K161019Uroview FDPausch Medical GmbH201621
+5K160301Platinum dRF Imaging SystemApelem-Dms Group20161—
+5K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+5K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+5K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+5K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+5K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+5K132773Sidexis 4Sirona Dental Systems GmbH20131—
+5K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+5K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+5K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+5K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+5K123575MammoworkstationImage Diagnost International GmbH20132—
+5K122768GenesisDornier Medtech America, Inc.20134—
+5K122457GE Innova/Innova Igs/Discovery Igs/Optima Angiographic, Fluoscopic X-Ray Systems with…GE Healthcare2013520
+5K121513Multix FusionSiemens Medical Solution2012324
+5K121838Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim201202
+5K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+5K120073Infx-8000V withToshibamedical Systems Corporation2012203
+5K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+5K113052Infinix-CciToshiba America Medical Systems, In.C201171
+5K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+5K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan20110—
+5K103038Duet DRFCmt Medical Technologies, Ltd.20111—
+5K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+5K101042BladeviewAccogent, LLC20100—
+5K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+5K082830Infx-8000H, Infinix-IToshiba America Medical Systems, In.C200812
+5K041949Allura Xper FD10Philips Medical Systems North America Co.20046448
+5K031836Philips Fresco Release 1Philips Medical Systems North America Co.200351—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K252503Intelligent NRCanon, Inc.20260—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+6K243884TavipilotCaranx Medical20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K221335D²RS and D²RS 9090Stephanix20220—
+6K203010Platinum dRF Imaging SystemApelem-Dms Group20210—
+6K200965XR-MX/1000Karl Storz Endoscopy America, Inc.20200—
+6K202235ArtPIX DRFCmt Medical Technologies, Ltd.20200—
+6K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+6K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+6K181403Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 ORGE Healthcare201836
+6K182546Alphenix, INFX-8000H/B, V8.0Canon Medical Systems Corporation201802
+6K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+6K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+6K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+6K180651Uroview FD IIPausch Medical GmbH20180—
+6K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+6K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+6K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+6K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+6K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+6K160620Visaris Vision® (Vision C, Vision U. Vision V, Vision X)Visaris D.O.O. Belgrade201623
+6K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…Summit Industries, LLC20162—
+6K152697Infx-8000C, V6.20Toshibamedical Systems Corporation201635
+6K152767OTC12D Auto Radiographic SystemDel Medical, Inc.20151—
+6K151485GenesisDornier Medtech America, Inc.20151—
+6K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+6K150663Diagnostic X-ray SystemOsko, Inc.20150—
+6K143361Mammo WorkstationGE Healthcare20151—
+6K143281Ultimax-iToshibamedical Systems Corporation20150—
+6K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+6K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc.201418—
+6K133434Genesis IIDornier Medtech America, Inc.20142—
+6K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+6K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc.20141412
+6K133535Infx-8000V, V5.30Toshibamedical Systems Corporation2014102
+6K133580Artis OneSiemens Medical Solutions USA, Inc.2014117
+6K133278Discovery Igs 740GE Medical Systems SCS201445
+6K132934Multix Select DRSiemens Medi Cal Solutions, Inc.20143—
+6K132558Sync-RX SystemVolcano Corporation201331
+6K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C20138—
+6K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…Philips Medical Systems Nederland B.V.20130Class I
+6K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+6K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+6K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+6K120514CardiopacsLumedx20120—
+6K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+6K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+6K062650EP Navigator SoftwarePhilips Medical Systems200649—
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.20260—
+7K253752ARTIS genio floor; ARTIS icono.explore floorSiemens Medical Solutions USA, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K2434463DXRGE Medical Systems SCS20250—