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
+6K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K221725Advanced MyHip PlannerMedacta International S.A.20230—
+6K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+6K213922FX SPSPixee Medical20222—
+6K213779Customize3D-Side S.A.20221—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+6K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+6K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+6K200274CariCloudCaristo Diagnostics20200—
+6K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+6K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+6K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+6K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+6K180307Mazor XMazor Robotics, Ltd.201817—
+6K173390hipEOSOnefit Medical20188—
+6K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+6K170540DM-DensityDensitas, Inc.20187—
+6K180091UNiD Spine AnalyzerMedicrea International20186—
+6K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+6K172522Mazor XMazor Robotics, Ltd.20170—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K152009DENSEEMAMMO v1.0Statlife20161—
+6K160937SenolrisGE Healthcare20160—
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K160914sterEOS WorkstationEos Imaging, Inc.20168—
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+6K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K142037QuantraHologic, Inc.20141—
+6K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+7K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+7K252214AIAS CephalonMetamorphosis GmbH20250—
+7K250290SurgiTwinTwinsight20250—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+7K250042PeekMed webPeek Health, S.A.20254—
+7K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K240582VEA Align; spineEOSEos Imaging20244—
+7K221432Customize3D-Side S.A.20220—
+7K220779XDMirada Medical, Ltd.20220—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+7K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+7K203785ClariSIGMAMClaripi, Inc.20210—
+7K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+7K201411Visage Breast DensityVisage Imaging GmbH20210—
+7K202700ART-PlanTherapanacea20215—
+7K200323AutoContourRadformation, Inc.20207—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K192973densitas densityaiDensitas, Inc.20205—
+7K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+7K190764SurgicalARMedivis, Inc.20196—
+7K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+7K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K173574DenSeeMammoStatlife20180—
+7K172346sterEOS WorkstationEos Imaging201871
+7K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K163623QuantraHologic, Inc.20170—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+7K161201ClearRead CTRiverain Technologies, LLC20165—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+7K133521Aze Phoenix SoftwareAze, Ltd.20140—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K113620Myrian 1.11Intrasense20126—
+7K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+7K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+8K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+8K251747VEA Align; spineEOSEos Imaging20251—
+8K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+8K251096PeekMed webPeek Health, S.A.20253—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—