510(k) Report

Devices descending from K962699

848 later devices reach Radworks Medical Imaging Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+8K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K250039HPACSHealthhub20250—
+8K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+8K2438492430TCA with Xmaru WRayence Co., Ltd.20250—
+8K241113Vivix-MVieworks Co., Ltd.20250—
+8K242270OrthoNext Platform SystemOrthofix Srl20240—
+8K243209nordicMEDiVANordicneurolab AS20240—
+8K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+8K241608nordicMEDiVANordicneurolab AS20241—
+8K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+8K233599X-Clever (ASHK100G)Lg Electronics.Inc20240—
+8K232479ART-PlanTherapanacea20232—
+8K231498TraumaCad NeoBrainlab, Ltd.20231—
+8K232555HarmonyTopcon Healthcare Solutions20231—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K230249IkshanaImmersivetouch20231—
+8K230252OFIX MIS AppOrthofix US, LLC20230—
+8K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+8K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+8K232185SM-IVSedecal., Sa.20230—
+8K232088Altris IMSAltris, Inc.20230—
+8K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+8K223841KBA3DS.M.A.I.O20231—
+8K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K230575Limbus ContourLimbus Ai, Inc.20231—
+8K213272Formus HipFormus Labs, Ltd.20230—
+8K221725Advanced MyHip PlannerMedacta International S.A.20230—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K222767PeekMed web (v1)Peek Health, S.A.20228—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K222951SM-VSedecal., Sa.20221—
+8K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+8K223060DigiX FDXAllengers Medical Systems Limited20224—
+8K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+8K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+8K213922FX SPSPixee Medical20222—
+8K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.Sedecal., Sa.202201
+8K221426Functional MR V1.0Olea Medical S.A.S.202201
+8K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+8K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+8K212915MVision AI SegmentationMVision AI20221—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K210344inVisionOSPrecisionos Technology, Inc.20210—
+8K212887RTappSegana, Inc.20210—
+8K211356GIQuantMotilent, Ltd.20210—
+8K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K202808Brainance MDAdvantis Medical Imaging Single Member P.C.20211—
+8K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K210556Preview ShoulderGenesis Software Innovations20213—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K203235VBrainVysioneer, Inc.20214—
+8K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K200822BraidBraid.Health20201—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K201575CMDR 2C (Multiple Models)Minxray, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K200726AcuityPDRRadmedix, LLC20209—
+8K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+8K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+8K192424Mobius3DVarian Medical Systems, Inc.20194—
+8K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+8K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+8K191051ARGOSSantec Corporation20190—
+8K190232Synapse PACSFujifilm Corporation2019311
+8K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+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—
+8K173475Merge PACSMerge Healthcare Incorporated201712
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+8K163668SuitestensaEbit Srl20170—
+8K170172UNiD Spine AnalyzerMedicrea International20177—
+8K170195QuantXQuantitative Insights, Inc.20174—
+8K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+8K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+8K163221Mazor XMazor Robotics, Ltd.201719—