510(k) Report

Devices descending from K941933

414 later devices reach Isg Medical Imaging Family of Workstations (Mifw) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+8K231917VEA AlignEos Imaging20245—
+8K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+8K230249IkshanaImmersivetouch20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K222275Saige-DensityDeepHealth, Inc.20221—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+8K220813Art-PlanTherapanacea20224—
+8K212915MVision AI SegmentationMVision AI20221—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+8K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K193252Contour ProtegeAIMim Software, Inc.20206—
+8K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+8K200935Mazor XMazor Robotics, Ltd.202015—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K182034Arterys MICAArterys, Inc.20183—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+9K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K252856PeekMed webPeek Health, S.A.20251—
+9K251078AutoDensityEos Imaging20250—
+9K252452PeekMed webPeek Health, S.A.20250—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+9K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K243705Saige-Density (2.5.0)DeepHealth, Inc.20240—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K241561MammoScreen BDTherapixel20241—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K233457RUSHutom, Inc.20240—
+9K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K230023ART-PlanTherapanacea Sas20233—
+9K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+9K210632Contour ProtegeAIMim Software, Inc.20215—
+9K203005Mazor XMazor Robotics, Ltd.2020141
+9K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+9K192437Arterys MICAArterys, Inc.20202—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+9K181892Ziostation2Ziosoft, Inc.20181—
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K163668SuitestensaEbit Srl20170—
+9K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+9K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+9K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+9K151233MonacoImpac Medical Systems, Inc.201569
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+10K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K243685MammoScreen BDTherapixel20250—
+10K252362GBrain MRIGalileo Cds, Inc.20250—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+10K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+10K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+10K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+10K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+10K232479ART-PlanTherapanacea20232—