510(k) Report

Devices descending from K003192

247 later devices reach Magnetic Concerto through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K113620Myrian 1.11Intrasense20126—
+6K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+7K261331I-Genius (100019400)Esaote, S.p.A.20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+7K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K180563syngo.plazaSiemens Healthcare GmbH20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K151212Ziostation2Qi Imaging, LLC20152—
+7K142750JiveXVisus Technology Transfer GmbH20156—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+8K252571mdprostateMediaire GmbH20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K220349TeraRecon NeuroTerarecon,Inc.20220—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+8K200132AshvinsMedicalcommunications GmbH202001
+8K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K181892Ziostation2Ziosoft, Inc.20181—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K162008JiveXVisus Technology Transfer GmbH20164—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K241440HealthCCSngNano-X AI, Ltd.20240—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K230112CAC SoftwareImbio, Inc.20230—
+9K230223iCAC DeviceBunkerhill, Inc.20236—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K200315Ziostation2Ziosoft, Inc.20200—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K181964JiveXVisus Health IT GmbH20183—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K260166Bunkerhill Contrast CACBunkerHill Health20260—