510(k) Report

Devices descending from K071310

195 later devices reach Syngo CT Oncology Software Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190178Monaco RTP SystemElekta, Inc.201945
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+5K142647mint LesionMint Medical GmbH201523
+6K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+6K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+6K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+6K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+6K233080HealthFLDNano-X AI, Ltd.20240—
+6K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K220929ExcelsiorMerit Cro, Inc.20220—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+6K202789Monaco Rtp SystemElekta Solutions AB20213—
+6K202229AI MetricsAi Metrics, LLC20200—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+6K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K242188ClearRead CT CACRiverain Technologies, 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—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+7K213787Monaco RTP SystemElekta Solutions AB20222—
+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—
+7K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K252571mdprostateMediaire GmbH20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K223233Monaco RTP SystemElekta Solutions AB20231—
+8K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+9K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+9K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+9K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K250367CoLumboXSmart Soft Healthcare AD20250—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+10K240793MSKaiMskai20240—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+10K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+11K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+11K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+11K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+11K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+12K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+12K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+13K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+14K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—