510(k) Report

Devices descending from K904519

438 later devices reach Agfa Diagnostic Center (Adc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161479hipEOSOnefit Medical20169—
+7K160407spineEOSOnefit Medical20166—
+7K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+7K150738VitreaViewVital Images, Inc.20158—
+7K143361Mammo WorkstationGE Healthcare20151—
+7K141137Stereos WorkstationEos Imaging20149—
+7K132742M-VU Breast DensityVucomp, Inc.201311—
+7K121916IntuitionTerarecon,Inc.201351
+7K121213VitreaadvancedVital Images, Inc.201281
+7K120472QuantraHologic, Inc.20123—
+7K102556Volpara, Version 1.3Matakina Technology Limited201024—
+7K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+8K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+8K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K243697MySpine WebPlannerMedacta International S.A.20250—
+8K240926PeekMed webPeek Health, S.A.20246—
+8K243189TumorSight VizSimBioSys, Inc.20241—
+8K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+8K240172Preview ShoulderGenesis Software Innovations20240—
+8K232086spineEOSEos Imaging20235—
+8K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+8K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K221725Advanced MyHip PlannerMedacta International S.A.20230—
+8K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+8K213922FX SPSPixee Medical20222—
+8K213779Customize3D-Side S.A.20221—
+8K210670BU-CADTaihao Medical, Inc.20213—
+8K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+8K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+8K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+8K201373DRX-CompassCarestream Health, Inc.202021
+8K200274CariCloudCaristo Diagnostics20200—
+8K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+8K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+8K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+8K180307Mazor XMazor Robotics, Ltd.201817—
+8K173390hipEOSOnefit Medical20188—
+8K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+8K170540DM-DensityDensitas, Inc.20187—
+8K180091UNiD Spine AnalyzerMedicrea International20186—
+8K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+8K172522Mazor XMazor Robotics, Ltd.20170—
+8K163232Vitrea ViewVital Images, Inc.20177—
+8K152009DENSEEMAMMO v1.0Statlife20161—
+8K160937SenolrisGE Healthcare20160—
+8K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+8K160914sterEOS WorkstationEos Imaging, Inc.20168—
+8K153289HealthmyneHealthmyne, Inc.20160—
+8K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+8K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+8K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+8K142037QuantraHologic, Inc.20141—
+8K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+8K130393Mirada RTXMirada Medical, Ltd.201336—
+8K102687Mirada RTMirada Medical, Ltd.201037—
+8K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+8K101228Mirada XDMirada Medical, Ltd.201070—
+8K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+9K260086CadAI-B DxBeamWorks, Inc.20260—
+9K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+9K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+9K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+9K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+9K252214AIAS CephalonMetamorphosis GmbH20250—
+9K250290SurgiTwinTwinsight20250—
+9K251766TumorSight VizSimBioSys, Inc.20250—
+9K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+9K250042PeekMed webPeek Health, S.A.20254—
+9K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+9K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+9K240582VEA Align; spineEOSEos Imaging20244—
+9K223842DRX - CompassCarestream Health, Inc.20231—
+9K221432Customize3D-Side S.A.20220—
+9K220779XDMirada Medical, Ltd.20220—
+9K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+9K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+9K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+9K203785ClariSIGMAMClaripi, Inc.20210—
+9K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+9K201411Visage Breast DensityVisage Imaging GmbH20210—
+9K202700ART-PlanTherapanacea20215—
+9K200323AutoContourRadformation, Inc.20207—
+9K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+9K192973densitas densityaiDensitas, Inc.20205—
+9K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+9K190764SurgicalARMedivis, Inc.20196—
+9K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+9K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+9K181572Workflow BoxMirada Medical, Ltd.201825—
+9K173574DenSeeMammoStatlife20180—
+9K172346sterEOS WorkstationEos Imaging201871
+9K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+9K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+9K173542Arterys Oncology DLArterys, Inc.20185—
+9K163623QuantraHologic, Inc.20170—
+9K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—