510(k) Report

Devices descending from K911752

849 later devices reach Icon Teleradiology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+9K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+9K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+9K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K250039HPACSHealthhub20250—
+9K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K242919V5med Lung AIV5med, Inc.20250—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+9K241113Vivix-MVieworks Co., Ltd.20250—
+9K242270OrthoNext Platform SystemOrthofix Srl20240—
+9K243209nordicMEDiVANordicneurolab AS20240—
+9K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+9K241608nordicMEDiVANordicneurolab AS20241—
+9K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+9K233599X-Clever (ASHK100G)Lg Electronics.Inc20240—
+9K232479ART-PlanTherapanacea20232—
+9K231498TraumaCad NeoBrainlab, Ltd.20231—
+9K232555HarmonyTopcon Healthcare Solutions20231—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K230249IkshanaImmersivetouch20231—
+9K230252OFIX MIS AppOrthofix US, LLC20230—
+9K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+9K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+9K232185SM-IVSedecal., Sa.20230—
+9K232088Altris IMSAltris, Inc.20230—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K223841KBA3DS.M.A.I.O20231—
+9K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K230575Limbus ContourLimbus Ai, Inc.20231—
+9K213272Formus HipFormus Labs, Ltd.20230—
+9K221725Advanced MyHip PlannerMedacta International S.A.20230—
+9K221796Cyware 4H and Cysart 4HAbys Medical20221—
+9K222767PeekMed web (v1)Peek Health, S.A.20228—
+9K221612ClearRead CTRiverain Technologies, Inc.20220—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K222951SM-VSedecal., Sa.20221—
+9K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+9K223060DigiX FDXAllengers Medical Systems Limited20224—
+9K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+9K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+9K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+9K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+9K213922FX SPSPixee Medical20222—
+9K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+9K221426Functional MR V1.0Olea Medical S.A.S.202201
+9K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+9K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+9K212915MVision AI SegmentationMVision AI20221—
+9K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+9K210831OnQ NeuroCortechs Labs, Inc.20213—
+9K210344inVisionOSPrecisionos Technology, Inc.20210—
+9K212887RTappSegana, Inc.20210—
+9K211356GIQuantMotilent, Ltd.20210—
+9K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+9K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+9K202808Brainance MDAdvantis Medical Imaging Single Member P.C.20211—
+9K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K210556Preview ShoulderGenesis Software Innovations20213—
+9K202928DV. TargetDeepvoxel, Inc.20210—
+9K203235VBrainVysioneer, Inc.20214—
+9K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K200822BraidBraid.Health20201—
+9K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+9K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+9K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+9K200726AcuityPDRRadmedix, LLC20209—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+9K192424Mobius3DVarian Medical Systems, Inc.20194—
+9K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+9K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+9K191051ARGOSSantec Corporation20190—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+9K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+9K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+9K182034Arterys MICAArterys, Inc.20183—
+9K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+9K163668SuitestensaEbit Srl20170—
+9K170172UNiD Spine AnalyzerMedicrea International20177—
+9K170195QuantXQuantitative Insights, Inc.20174—
+9K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+9K170171IOLMaster 700Carl Zeiss Meditec, AG201731