510(k) Report

Devices descending from K910839

197 later devices reach Ultimate 3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213944HealthOSTNanoxai, Ltd.20221—
+10K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+10K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+10K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+10K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+10K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+10K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+10K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+10K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+10K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+10K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+10K142647mint LesionMint Medical GmbH201523
+11K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+11K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+11K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+11K241440HealthCCSngNano-X AI, Ltd.20240—
+11K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+11K233080HealthFLDNano-X AI, Ltd.20240—
+11K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+11K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+11K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+11K230112CAC SoftwareImbio, Inc.20230—
+11K230223iCAC DeviceBunkerhill, Inc.20236—
+11K220929ExcelsiorMerit Cro, Inc.20220—
+11K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+11K202229AI MetricsAi Metrics, LLC20200—
+11K201948AcroDTI VisualizerAcroviz, Inc.20200—
+11K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+11K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+11K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+11K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+11K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+11K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+11K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+11K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+12K260166Bunkerhill Contrast CACBunkerHill Health20260—
+12K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+12K250662Bunkerhill MACBunkerHill Health20250—
+12K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+12K243229Bunkerhill AVCBunkerHill Health20253—
+12K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+12K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+12K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+12K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+12K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+12K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+12K200899Quantib AI NodeQuantib B.V.20200—
+12K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+12K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+12K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+13K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+13K252571mdprostateMediaire GmbH20260—
+13K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+13K253690LungMapsSiemens Healthineers AG20260—
+13K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+13K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+13K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+13K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+13K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+13K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+13K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+13K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+13K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+14K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+14K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+14K241211CoLumboSmart Soft Healthcare20242—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K220497CoLumboSmart Soft Healthcare AD20226—
+14K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+14K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K250367CoLumboXSmart Soft Healthcare AD20250—
+15K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+15K240793MSKaiMskai20240—
+15K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+15K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+15K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+16K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+16K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+16K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+17K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+17K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+18K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+19K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—