510(k) Report

Devices descending from K022692

252 later devices reach Voxelplus Pacs through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+6K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+6K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+6K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+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—
+9K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K241440HealthCCSngNano-X AI, Ltd.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233080HealthFLDNano-X AI, Ltd.20240—
+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—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+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—
+10K260166Bunkerhill Contrast CACBunkerHill Health20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+10K250662Bunkerhill MACBunkerHill Health20250—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K243229Bunkerhill AVCBunkerHill Health20253—
+10K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—