510(k) Report

Devices descending from K003266

440 later devices reach Siremobil Iso-C 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K240465O-arm O2 Imaging SystemMedtronic Navigation, Inc.202402
+6K233875Brainomix 360 e-LungBrainomix Limited20241—
+6K232412LungQ v3.0.0Thirona BV20241—
+6K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+6K230985Planmeca VisoPlanmeca Oy20233—
+6K231692Ziehm Vision RFDZiehm Imaging GmbH20232—
+6K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K223556DeepCatchMedical IP Co., Ltd.20231—
+6K230505Orthopantomograph™ OP 3D LXPalodex Group OY20231—
+6K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+6K221344nView s1 with nav optionNview Medical20220—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K221230TRONXoran Technologies, LLC20220—
+6K213278Planmed VerityPlanmed OY20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp.20211—
+6K212494Lung Image AnalysisPulmonx Corporation20210—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202749ADAPT for Gamma3Stryker GmbH20200—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+6K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.20181—
+6K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…Villa Sistemi Medicali S.P.A.20181—
+6K171199AVIEWCoreline Soft Co., Ltd.20186—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K181576Planmeca VisoPlanmeca Oy20184—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181983PreXion 3D ExcelsiorPrexion Corporation20180—
+6K181136CS 9600Trophy201811
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163221Mazor XMazor Robotics, Ltd.201719—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K160525RCT700Ray Co., Ltd.201611—
+6K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+6K142247Rayscan a-Expert 3DRay Co., Ltd.201522—
+6K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K133544OP300Palodex Group OY20147—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+6K131695Rayscan a-Expert 3DRay Co., Ltd.201323—
+6K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K113620Myrian 1.11Intrasense20126—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+7K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K252735C-beamPulmera, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+7K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+7K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+7K250766LungQ 4Thirona BV20250—
+7K251484CT:VQ4Dmedical Limited20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K242411Brainomix 360 e-LungBrainomix Limited20250—
+7K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)Palodex Group OY20240—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K240099Ziehm Vision RFDZiehm Imaging GmbH202411
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L.20200—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K200714AVIEWCoreline Soft Co., Ltd.20205—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K200183CS 9600Trophy202001
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—