510(k) Report

Devices descending from K011447

244 later devices reach IN Space 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152696Infx-8000V, V6.20Toshibamedical Systems Corporation201681
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+5K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K113620Myrian 1.11Intrasense20126—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+6K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+6K250766LungQ 4Thirona BV20250—
+6K251484CT:VQ4Dmedical Limited20250—
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K242411Brainomix 360 e-LungBrainomix Limited20250—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K233080HealthFLDNano-X AI, Ltd.20240—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K200714AVIEWCoreline Soft Co., Ltd.20205—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+6K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K233457RUSHutom, Inc.20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K214036AVIEWCoreline Soft Co., Ltd.20224—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K200899Quantib AI NodeQuantib B.V.20200—
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+7K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+7K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K252571mdprostateMediaire GmbH20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K243689AVIEWCoreline Soft Co., Ltd.20250—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K233211Aview CacCoreline Soft Co., Ltd.20242—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+8K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—