510(k) Report

Devices descending from K984634

245 later devices reach 3D-Angio through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+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—
+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—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+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—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+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—
+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—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+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—
+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—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+7K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K233457RUSHutom, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K214036AVIEWCoreline Soft Co., Ltd.20224—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+8K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+8K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K243689AVIEWCoreline Soft Co., Ltd.20250—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K233211Aview CacCoreline Soft Co., Ltd.20242—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+9K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—