510(k) Report

Devices descending from K941223

478 later devices reach Advance Analysis Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K202990NinesMeasureNines, Inc.20211—
+7K201501VeolityMeVis Medical Solutions AG20210—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K193220Aview LCSCoreline Soft Co., Ltd.20201—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K182230Multi Modality ViewerVital Images, Inc.20180—
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+7K163668SuitestensaEbit Srl20170—
+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—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated201111—
+7K112446Tomotherapy Treatment SystemTomotherapy Incorporated20110—
+7K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+7K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+7K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+7K091001Myrian 1.4Intrasense20097—
+7K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+7K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+7K071362Vital Connect 4.1Vital Images, Inc.2007113
+7K071331Vitrea Version 4.0Vital Images, Inc.2007821
+7K071000MyrianIntrasense20078—
+7K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+7K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K250039HPACSHealthhub20250—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K240786AutoChamberHeartLung Corporation20241—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K233457RUSHutom, Inc.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K232479ART-PlanTherapanacea20232—
+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—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K203744Arterys MICAArterys, Inc.20221—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K201710A View LCSCoreline Soft Co., Ltd.20200—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K200822BraidBraid.Health20201—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K163071vascuCAPElucid Bioimaging, Inc.20173—
+8K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—