510(k) Report

Devices descending from K960635

211 later devices reach Pulmo CT with Reference Database for the Somatom Plus and Plus 4 Computed… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K243689AVIEWCoreline Soft Co., Ltd.20250—
+7K233211Aview CacCoreline Soft Co., Ltd.20242—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+8K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243696Aview CacCoreline Soft Co., Ltd.20250—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230112CAC SoftwareImbio, Inc.20230—
+8K230223iCAC DeviceBunkerhill, Inc.20236—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K260166Bunkerhill Contrast CACBunkerHill Health20260—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K250662Bunkerhill MACBunkerHill Health20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K243229Bunkerhill AVCBunkerHill Health20253—
+9K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—